Trial Outcomes & Findings for Two Year Study With Robotic-Arm Assisted Hip Surgery. (NCT NCT03891199)

Last Updated: 2024-03-12

Results Overview

Accuracy of cup placement will be measured by absolute value of degrees from target version (40 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2024-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Control Traditional THA.	Intervention Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two Year Study With Robotic-Arm Assisted Hip Surgery.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Version.	5.95 degrees error in anteversion Standard Deviation 2.78	4.26 degrees error in anteversion Standard Deviation 3.19

PRIMARY outcome

Timeframe: 1 Year

The hip disability and osteoarthritis outcome score (HOOS) is a questionnaire intended to be used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process . To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up.

Outcome measures

Outcome measures
Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. HOOS Pain Improvement	39.54 score on a scale Standard Deviation 9.98	47.92 score on a scale Standard Deviation 6.34
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. HOOS ADL (activities of daily living)	41.31 score on a scale Standard Deviation 9.98	48.40 score on a scale Standard Deviation 4.59
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. HOOS Symptoms	32.27 score on a scale Standard Deviation 10.65	59.17 score on a scale Standard Deviation 4.99
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. HOOS QOL (quality of life)	43.75 score on a scale Standard Deviation 11.46	53.13 score on a scale Standard Deviation 9.05
Change in Patient Reported "Hip Dysfunction and Osteoarthritis Outcome Score" (HOOS) Survey Over 1 Year Period. HOOS Sports/recreation	31.82 score on a scale Standard Deviation 12.93	58.85 score on a scale Standard Deviation 6.63

PRIMARY outcome

Timeframe: 1year

The PROMIS Global-10 is a global health quality of life patient reported outcome tool. It is part of the Patient-Reported Outcomes Measurement Information System (PROMIS). It measures symptoms, functioning, and healthcare quality of life for a wide variety of conditions. The PROMIS Global-10 consists of 10 questions assessing physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. 7 questions inquire about health in "general" and 3 questions assess emotional problems, fatigue and pain in the last 7 days. PROMIS 10 Global Physical Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse physical health and 20 equals the best physical health). PROMIS 10 Global Mental Health- Scale range (0-20) and what the low number means vs the high number (ex 0 equals worse mental health and 20 equals the best mental health)

Outcome measures

Outcome measures
Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period. PROMIS 10 Global Physical Health	10.11 score on a scale Standard Deviation 3.01	11.37 score on a scale Standard Deviation 2.72
Change in "Patient-Reported Outcomes Measurement Information System" (PROMIS) Survey Over a 1 Year Period. PROMIS 10 Global Mental Health	3.92 score on a scale Standard Deviation 3.38	2.88 score on a scale Standard Deviation 1.73

PRIMARY outcome

Timeframe: 6 months

Accuracy of cup placement will be measured by absolute value of degrees from target inclination (20 degrees). Using CT (Computed Tomography) Scans, analysis and radiographs will allow for a complete description of cup placement, and better accounts for factors such as pelvic rotation and/or tilt, otherwise not accounted for in radiographic analysis alone.

Outcome measures

Outcome measures
Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Accuracy of Acetabular Cup Placement Manually vs. Robotic-arm Assisted - Inclination.	4.73 degrees error in inclination Standard Deviation 3.58	2.93 degrees error in inclination Standard Deviation 2.42

PRIMARY outcome

Timeframe: 6 month

5-25 degrees of anteversion; 30-50 degrees of inclination.

Outcome measures

Outcome measures
Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Adherence to Lewinnek Safe Zone version in the Lewinnek safe zone	14 Participants	16 Participants
Adherence to Lewinnek Safe Zone inclination in the Lewinnek safe zone	17 Participants	17 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control n=20 participants at risk Traditional THA.	Intervention n=20 participants at risk Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
Musculoskeletal and connective tissue disorders Prosthetic Joint Infection	0.00% 0/20 • 1 year	5.0% 1/20 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Brock A. Lindsey, MD

West Virginia University

Phone: 304-293-1317

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Control n=20 Participants Traditional THA.	Intervention n=17 Participants Robotic-arm assisted THA. Robotic-Arm Assisted THA: The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants