Trial Outcomes & Findings for Anterior Advantage With KINCISE (NCT NCT04191733)

NCT ID: NCT04191733

Last Updated: 2023-09-15

Results Overview

Mean femoral broach time (in minutes) was collected intraoperatively and begun at the time the box osteotome first enters the femoral canal and ended with seating of the final broach trial within the femoral canal.

Recruitment status

TERMINATED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

Day 0 (operative day)

Results posted on

2023-09-15

Participant Flow

A total of 250 participants were enrolled in this study, out of which 7 participants withdrew study before assignment to any treatment. Hence, only 243 participants were included in the analysis.

Participant milestones

Participant milestones
Measure	Arm 1: KINCISE Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Overall Study STARTED	122	121
Overall Study Enrolled But Not Treated	5	10
Overall Study Safety Population	117	111
Overall Study COMPLETED	101	95
Overall Study NOT COMPLETED	21	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: KINCISE Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Overall Study Withdrawn due to study closure	13	14
Overall Study Withdrawal by Subject	2	4
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	5	6
Overall Study Death	0	1

Baseline Characteristics

Anterior Advantage With KINCISE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: KINCISE n=117 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=111 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).	Total n=228 Participants Total of all reporting groups
Age, Continuous	64.3 Years STANDARD_DEVIATION 8.65 • n=5 Participants	64.5 Years STANDARD_DEVIATION 9.42 • n=7 Participants	64.4 Years STANDARD_DEVIATION 9.01 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	62 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	49 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	82 Participants n=7 Participants	170 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	89 Participants n=7 Participants	190 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (operative day)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not have any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=107 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=109 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Mean Femoral Broach Time	5.8 Minutes Standard Deviation 4.01	8.1 Minutes Standard Deviation 6.06

SECONDARY outcome

Timeframe: Day 0 (operative day)

Skin-to-skin is the time (in minutes) duration of the surgery procedure.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=109 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=109 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Skin-to-skin Time	71.0 Minutes Standard Deviation 18.15	70.2 Minutes Standard Deviation 15.61

SECONDARY outcome

Timeframe: At Week 6 (post operative)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with optimal acetabular cup (a socket of the hip joint) abduction angle (movement of the leg away from the midline of the body) within +/- 10 degree of plan at Week 6 was reported.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Optimal Acetabular Cup Abduction Angle at Week 6	98 Participants	95 Participants

SECONDARY outcome

Timeframe: At Week 6 (post operative)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with optimal acetabular cup (a socket of the hip joint) version angle (rotation of leg in hip joint) within +/- 10 degrees of plan at Week 6 was reported.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=101 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=94 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Optimal Acetabular Cup Version Angle at Week 6	93 Participants	88 Participants

SECONDARY outcome

Timeframe: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

The HHS was developed for the assessment of the results of hip surgery. HHS was intended to evaluate various hip disabilities and methods of treatment in an adult population. It consisted of 10 items covering four domains: pain (1 item, 0-44 points), function ( 7 items \[limb, support, distance walked, stairs, socks/shoes, sitting and public transportation\], 0-47 points), deformity (1 item, 4 points) and range of hip motion (1 items, 5 points). HHS total score was the sum of 10 items scores and ranged from 0 (worse disability) to 100 (less disability). The higher score indicated better outcome for the participant. The scores were interpreted as follows: \< 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. Day 0 was the operative day.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=100 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=98 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24 Week 6	29.0 Units on a scale Standard Deviation 18.32	27.3 Units on a scale Standard Deviation 18.95
Change From Pre-operative Baseline in Harris Hip Score (HHS) at Weeks 6 and 24 Week 24	38.7 Units on a scale Standard Deviation 14.43	41.0 Units on a scale Standard Deviation 14.93

SECONDARY outcome

Timeframe: 6-week post-operative to 24 weeks post-operatively

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed)=who were evaluable for this outcome measure.

The FJS was a 12 question form that asks the participants their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Response to each question was individually scored (0 to 4, where 0=never, 1=almost never, 2=seldom, 3=sometimes and 4=mostly) and summed to create a raw composite score that was normalized to a range of 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the artificial joint in everyday life).

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=87 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=84 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Change From 6-week Post-surgery in Forgotten Joint Score (FJS-12) at Week 24	25.3 Units on a scale Standard Deviation 27.68	22.2 Units on a scale Standard Deviation 26.40

SECONDARY outcome

Timeframe: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicated better QoL.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=100 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=97 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24 Week 6	0.18 Units on a scale Standard Deviation 0.164	0.16 Units on a scale Standard Deviation 0.187
Change From Pre-operative Baseline in European Quality of Life (EuroQol)-5 Dimension-5 Level (EQ-5D-5L) Heath State Index Total Score at Weeks 6 and 24 Week 24	0.25 Units on a scale Standard Deviation 0.162	0.28 Units on a scale Standard Deviation 0.173

SECONDARY outcome

Timeframe: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

EQ-5D-5L was a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=100 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=98 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24 Week 6	12.3 Units on a scale Standard Deviation 16.52	10.0 Units on a scale Standard Deviation 16.52
Change From Pre-operative Baseline in EQ-5D-5L Visual Analog Scale (VAS) Total Score at Weeks 6 and 24 Week 24	12.8 Units on a scale Standard Deviation 15.26	11.9 Units on a scale Standard Deviation 17.97

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with pain (Groin, and Buttock) at Weeks 6 and 24 was reported. Participant's groin pain and buttock pain was reported either as none, mild, moderate, or severe.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=102 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=98 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Groin pain · None	57 Participants	60 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Groin pain · Mild	38 Participants	27 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Groin pain · Moderate	6 Participants	11 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Groin pain · Severe	0 Participants	0 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Groin pain · Missing	1 Participants	0 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Groin pain · None	78 Participants	72 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Groin pain · Mild	15 Participants	18 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Groin pain · Moderate	1 Participants	2 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Groin pain · Severe	1 Participants	1 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Groin pain · Missing	0 Participants	0 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Buttock pain · None	66 Participants	61 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Buttock pain · Mild	31 Participants	30 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Buttock pain · Moderate	5 Participants	6 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Buttock pain · Severe	0 Participants	1 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 6: Buttock pain · Missing	0 Participants	0 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Buttock pain · None	81 Participants	80 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Buttock pain · Mild	11 Participants	11 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Buttock pain · Moderate	2 Participants	2 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Buttock pain · Severe	1 Participants	0 Participants
Number of Participants With Pain (Groin, and Buttock) at Weeks 6 and 24 Week 24: Buttock pain · Missing	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with post-operative satisfaction with the procedure at Weeks 6 and 24 was reported. Participants were asked a question that "How satisfied do you anticipate you will be with this procedure?" and participant responded on a 5-point scale (1=extremely satisfied, 2=very satisfied, 3=moderately satisfied, 4=slightly satisfied, 5=not at all satisfied). Higher score indicated low post-operative satisfaction.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=102 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=98 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Extremely satisfied	80 Participants	66 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Very satisfied	15 Participants	23 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Moderately satisfied	5 Participants	6 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Slightly satisfied	0 Participants	2 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Not at all satisfied	1 Participants	0 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 6 · Missing	1 Participants	1 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Extremely satisfied	78 Participants	77 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Very satisfied	13 Participants	12 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Moderately satisfied	2 Participants	2 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Slightly satisfied	1 Participants	0 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Not at all satisfied	1 Participants	2 Participants
Number of Participants With Post-operative Satisfaction With the Procedure at Weeks 6 and 24 Week 24 · Missing	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 6 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Participants were asked the following questions: "Can you walk without an aid?", "Do you drive?", "Can you perform basic activities of daily living without assistance?", "Can you perform light household duties?", "Can you perform moderate to heavy household duties?", "Can you go up and down a flight of stairs using a handrail?", "Can you put on socks/stockings without someone's assistance?", "Can you bend down to pick up an object on the floor?", "Can you stand up from a chair without assistance?", "Can you participate in leisure recreational activities?", "Do you work?" and "When were you first able to accomplish the primary goal you identified after surgery?". Participants were asked to respond either as "yes" or "No, because of study hip". Number of participants who reported response as "yes" at Week 6 were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=106 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=107 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Post-operative Functional Recovery at Week 6 Can you walk without an aid?	96 Participants	95 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Do you drive?	98 Participants	93 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you perform basic activities of daily living without assistance?	104 Participants	103 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you perform light household duties?	100 Participants	99 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you perform moderate to heavy household duties?	75 Participants	68 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you go up and down a flight of stairs using a handrail?	96 Participants	96 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you put on socks/stockings without someone's assistance?	94 Participants	90 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you bend down to pick up an object on the floor?	98 Participants	98 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you stand up from a chair without assistance?	102 Participants	104 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Can you participate in leisure recreational activities?	65 Participants	52 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 Do you work?	46 Participants	37 Participants
Number of Participants With Post-operative Functional Recovery at Week 6 When were you first able to accomplish primary goal you identified after surgery?	62 Participants	63 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcomes (acetabular cup migration, acetabular cup radiolucency, acetabular cup progressive radiolucency, acetabular cup osteolysis, acetabular cup sclerotic lines, acetabular cup porous coating integrity, femoral stem subsidence, femoral stem radiolucency, femoral stem osteolysis, calcar resorption, calcar fracture, femoral stem tilt and femoral stem porous coating integrity) were reported. In this outcome measure, only those timepoints in which participants had data were reported. In this outcome measure, each radiographic outcome assessment was reported either as present or absent in the analyzed participants.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Sclerotic Lines: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Migration: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Migration: Absent	93 Participants	92 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Radiolucency: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Radiolucency: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Radiolucency: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Radiolucency: Absent	95 Participants	93 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Progressive Radiolucency: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Progressive Radiolucency: Absent	91 Participants	88 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Osteolysis: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Osteolysis: Absent	93 Participants	92 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Sclerotic Lines: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Sclerotic Lines: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Sclerotic Lines: Absent	95 Participants	93 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Porous Coating Integrity: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Acetabular Cup Porous Coating Integrity: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Porous Coating Integrity: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Acetabular Cup Porous Coating Integrity: Absent	95 Participants	93 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Subsidence: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Subsidence: Absent	93 Participants	92 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Femoral Stem Radiolucency: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Femoral Stem Radiolucency: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Radiolucency: Present	0 Participants	1 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Radiolucency: Absent	95 Participants	92 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Osteolysis: Present	1 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Osteolysis: Absent	92 Participants	92 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Calcar Resorption: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Calcar Resorption: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Calcar Resorption: Present	1 Participants	2 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Calcar Resorption: Absent	94 Participants	91 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Calcar Fracture: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Calcar Fracture: Absent	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Calcar Fracture: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Calcar Fracture: Absent	95 Participants	93 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral stem tilt: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral stem tilt: Absent	12 Participants	17 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral stem tilt: Not applicable	79 Participants	71 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Femoral Stem Porous Coating Integrity: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Femoral Stem Porous Coating Integrity: Absent	75 Participants	73 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 6: Femoral Stem Porous Coating Integrity: Not applicable	28 Participants	26 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Porous Coating Integrity: Present	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Porous Coating Integrity: Absent	69 Participants	67 Participants
Number of Participants With Radiographic Outcomes: Assessed on Acetabular Cup, Femoral Stem, Calcar Resorption and Calcar Fractur Week 24: Femoral Stem Porous Coating Integrity: Not applicable	26 Participants	26 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (femoral stem position) were reported. Femoral stem position was assessed as neutral, varus and valgus.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 6: Neutral	91 Participants	82 Participants
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 6: Varus	10 Participants	16 Participants
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 6: Valgus	2 Participants	1 Participants
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 24: Neutral	83 Participants	76 Participants
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 24: Varus	10 Participants	16 Participants
Number of Participants With Radiographic Outcomes: Femoral Stem Position Week 24: Valgus	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (device/anatomy condition) were reported. Assessments were reported as intact or not intact.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition Week 24: Non-intact	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition Week 6: Intact	103 Participants	99 Participants
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition Week 6: Non-intact	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Device/Anatomy Condition Week 24: Intact	95 Participants	93 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (heterotopic ossification) were reported. Ossification is defined as formation of extraskeletal bone in muscle and soft tissues. Heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist. Heterotopic ossification was classified as Class 0, I, II, III and IV where Class 0 indicates "no evidence heterotopic bone formation", Class I indicates "islands of bone within the soft tissue about the hip", Class II indicates "bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter (cm) between opposing bone surfaces", Class III indicates "bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm", and Class IV indicates "apparent bone ankylosis of the hip."

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 6: Class 0	100 Participants	89 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 6: Class I	2 Participants	9 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 6: Class II	1 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 6: Class III	0 Participants	1 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 6: Class IV	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 24: Class 0	90 Participants	81 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 24: Class I	4 Participants	10 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 24: Class II	1 Participants	2 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 24: Class III	0 Participants	0 Participants
Number of Participants With Radiographic Outcomes: Heterotopic Ossification Week 24: Class IV	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Radiographic outcome was assessed on acetabular cup version (hip) and acetabular cup inclination and reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=103 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=99 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination Week 6: Acetabular Cup Version: Hip	25.2 Degrees Standard Deviation 2.83	25.3 Degrees Standard Deviation 2.70
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination Week 24: Acetabular Cup Version: Hip	25.3 Degrees Standard Deviation 2.72	25.2 Degrees Standard Deviation 2.33
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination Week 6: Acetabular Cup Inclination	43.9 Degrees Standard Deviation 3.83	43.8 Degrees Standard Deviation 3.79
Radiographic Outcomes: Assessment of Acetabular Cup Version (Hip) and Acetabular Cup Inclination Week 24: Acetabular Cup Inclination	43.8 Degrees Standard Deviation 3.71	43.6 Degrees Standard Deviation 3.57

SECONDARY outcome

Timeframe: From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)

Length of hospital stay (in days) after index THA was calculated from date of discharge minus date of surgery.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=109 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=109 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Length of Hospital Stay After Index Total Hip Arthroplasty (THA)	0.8 Days Standard Deviation 0.75	0.7 Days Standard Deviation 0.65

SECONDARY outcome

Timeframe: Day 0 (operative day) to Day 90 (post-operative)

Number of participants with re-hospitalizations during the study was reported.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=109 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=109 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Re-hospitalization During the Study	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From post operation (Day 0) to Week 24

Number of participants who received any narcotic pain medication to manage study hip pain was reported.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=109 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=109 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Narcotic Pain Medication Usage	99 Participants	100 Participants

SECONDARY outcome

Timeframe: Day 0 (operative day) up to Week 24

Population: The safety population set consisted of all participants in the enrolled population set for whom treatment was attempted, according to the actual treatment received.

Number of participants who experienced post-operative complication was reported.

Outcome measures

Outcome measures
Measure	Arm 1: KINCISE n=117 Participants Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=111 Participants Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Number of Participants With Post-operative Complications	13 Participants	10 Participants

Adverse Events

Arm 1: KINCISE

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Arm 2: MALLET

Serious events: 3 serious events

Other events: 8 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1: KINCISE n=117 participants at risk Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=111 participants at risk Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Infections and infestations Wound infection	0.00% 0/117 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/117 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Nervous system disorders Cerebrovascular accident	0.00% 0/117 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.

Other adverse events

Additional Information

FRANCHISE MEDICAL DIRECTOR

DePuy Orthopaedics

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm 1: KINCISE n=117 participants at risk Participants indicated to receive primary uncemented total hip arthroplasty (THA) underwent Anterior Advantage approach in THA using KINCISE surgical automated system.	Arm 2: MALLET n=111 participants at risk Participants indicated to receive primary uncemented THA underwent Anterior Advantage approach in THA using MALLET (a surgical hammer like instrument, without KINCISE surgical automated system).
Musculoskeletal and connective tissue disorders Arthralgia	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Groin pain	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Joint stiffness	2.6% 3/117 • Number of events 3 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Joint swelling	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Musculoskeletal and connective tissue disorders Tendonitis	1.7% 2/117 • Number of events 2 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Injury, poisoning and procedural complications Extraskeletal ossification	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Injury, poisoning and procedural complications Fall	0.00% 0/117 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Injury, poisoning and procedural complications Femur fracture	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	2.7% 3/111 • Number of events 3 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/117 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.90% 1/111 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Injury, poisoning and procedural complications Wound dehiscence	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Nervous system disorders Cerebrospinal fluid leakage	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Nervous system disorders Meralgia paraesthetica	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
Nervous system disorders Paraesthesia	1.7% 2/117 • Number of events 2 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
General disorders Swelling	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.
General disorders Peripheral swelling	0.85% 1/117 • Number of events 1 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.	0.00% 0/111 • From Baseline (Day 0) up to end of study (up to 31 months) The safety population set consisted of all enrolled participants who signed the informed consent document and attempted treatment according to the actual treatment received.