Trial Outcomes & Findings for Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty (NCT NCT02520531)

NCT ID: NCT02520531

Last Updated: 2024-02-22

Results Overview

Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

5 years follow-up

Results posted on

2024-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Scorpio PS Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Overall Study STARTED	42	42
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Scorpio PS Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Overall Study Revision of study device components	2	2
Overall Study Death	1	2
Overall Study Lost to Follow-up	1	1
Overall Study Meet exclusion criterion	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Not study device	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scorpio PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=84 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=42 Participants	15 Participants n=42 Participants	34 Participants n=84 Participants
Age, Categorical >=65 years	23 Participants n=42 Participants	27 Participants n=42 Participants	50 Participants n=84 Participants
Age, Continuous	65.44 years STANDARD_DEVIATION 8.01 • n=42 Participants	66.22 years STANDARD_DEVIATION 8.09 • n=42 Participants	65.83 years STANDARD_DEVIATION 8.06 • n=84 Participants
Sex: Female, Male Female	18 Participants n=42 Participants	19 Participants n=42 Participants	37 Participants n=84 Participants
Sex: Female, Male Male	24 Participants n=42 Participants	23 Participants n=42 Participants	47 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	42 participants n=42 Participants	42 participants n=42 Participants	84 participants n=84 Participants

PRIMARY outcome

Timeframe: 5 years follow-up

Population: At the 5 years follow-up data of 36 participants per study arm were analyzed.

Outcome measures

Outcome measures
Measure	Scorpio PS n=36 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=36 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Comparison of Maximum Passive and Active Flexion. Passive range of motion	124.58 degree Standard Deviation 10.04	125.14 degree Standard Deviation 23.01
Comparison of Maximum Passive and Active Flexion. Passive Flexion	126.64 degree Standard Deviation 9.22	131.33 degree Standard Deviation 8.49
Comparison of Maximum Passive and Active Flexion. Passive Extension	1.81 degree Standard Deviation 2.33	2.72 degree Standard Deviation 2.48
Comparison of Maximum Passive and Active Flexion. Active range of motion	118.64 degree Standard Deviation 10.15	125.72 degree Standard Deviation 8.66
Comparison of Maximum Passive and Active Flexion. Active Extension	0.61 degree Standard Deviation 1.08	0.97 degree Standard Deviation 1.50
Comparison of Maximum Passive and Active Flexion. Active Flexion	120.11 degree Standard Deviation 9.77	126.69 degree Standard Deviation 8.75

SECONDARY outcome

Timeframe: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up

Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed

The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.

Outcome measures

Outcome measures
Measure	Scorpio PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Knee Society Score (KSS) Pain motion Score pre-op	47.65 units on a scale Standard Deviation 11.18	49.85 units on a scale Standard Deviation 15.31
Knee Society Score (KSS) Pain motion Score 6 weeks	61.65 units on a scale Standard Deviation 16.45	69.63 units on a scale Standard Deviation 17.22
Knee Society Score (KSS) Pain motion Score 12 weeks	67.66 units on a scale Standard Deviation 13.00	75.38 units on a scale Standard Deviation 13.34
Knee Society Score (KSS) Pain motion Score 26 weeks	71.58 units on a scale Standard Deviation 14.61	74.70 units on a scale Standard Deviation 14.01
Knee Society Score (KSS) Pain motion Score 1 year	70.27 units on a scale Standard Deviation 12.39	73.83 units on a scale Standard Deviation 13.98
Knee Society Score (KSS) Pain motion Score 2 years	71.29 units on a scale Standard Deviation 13.96	74.79 units on a scale Standard Deviation 12.11
Knee Society Score (KSS) Pain motion Score 5 years	69.42 units on a scale Standard Deviation 11.94	74.85 units on a scale Standard Deviation 11.39
Knee Society Score (KSS) Function Score pre-op	61.55 units on a scale Standard Deviation 12.12	60.12 units on a scale Standard Deviation 15.36
Knee Society Score (KSS) Function Score 6 weeks	56.63 units on a scale Standard Deviation 15.83	60.83 units on a scale Standard Deviation 19.16
Knee Society Score (KSS) Function Score 12 weeks	73.29 units on a scale Standard Deviation 19.09	82.80 units on a scale Standard Deviation 14.88
Knee Society Score (KSS) Function Score 26 weeks	87.93 units on a scale Standard Deviation 15.49	90.25 units on a scale Standard Deviation 17.76
Knee Society Score (KSS) Function Score 1 year	88.46 units on a scale Standard Deviation 14.38	94.88 units on a scale Standard Deviation 12.67
Knee Society Score (KSS) Function Score 2 years	86.79 units on a scale Standard Deviation 22.52	95.24 units on a scale Standard Deviation 10.00
Knee Society Score (KSS) Function Score 5 years	87.92 units on a scale Standard Deviation 22.05	95.14 units on a scale Standard Deviation 10.45

SECONDARY outcome

Timeframe: pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up

Population: In some cases it was missed to do the Chair rise test.

A measurement to assess functional lower extremity strength. The participant is seated on a chair. Arms are crossed at the wrists and held against the chest. The participant is instructed to arise from an adjustable chair with the knees in a 90 degree angle (measurement with Goniometer) without using arms.

Outcome measures

Outcome measures
Measure	Scorpio PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Chair Raise Test Can arise from chair pre-operative	26 Participants	30 Participants
Chair Raise Test Can arise from chair at 6 weeks	34 Participants	37 Participants
Chair Raise Test Can arise from chair at 12 weeks	39 Participants	39 Participants
Chair Raise Test Can arise from chair at 26 weeks	40 Participants	38 Participants
Chair Raise Test Can arise from chair at 1 year	37 Participants	39 Participants
Chair Raise Test Can arise from chair at 2 years	39 Participants	36 Participants
Chair Raise Test Can arise from chair at 5 years	34 Participants	34 Participants

SECONDARY outcome

Timeframe: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.

The WOMAC collects information specific to osteoarthritis outcomes. The patient response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limited in function, and 4 indicating extreme pain stiffness, or limited in function. Total WOMAC scores range from 0 to 96 wit lower values representing better outcomes.

Outcome measures

Outcome measures
Measure	Scorpio PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
WOMAC Patient Questionnaire Total score pre-operative	49.33 units on a scale Standard Deviation 14.37	47.63 units on a scale Standard Deviation 15.84
WOMAC Patient Questionnaire Total score 12 weeks	26.56 units on a scale Standard Deviation 15.53	18.69 units on a scale Standard Deviation 15.22
WOMAC Patient Questionnaire Total score 26 weeks	19.95 units on a scale Standard Deviation 16.66	20.21 units on a scale Standard Deviation 19.24
WOMAC Patient Questionnaire Total score 1 year	19.74 units on a scale Standard Deviation 16.68	12.98 units on a scale Standard Deviation 13.78
WOMAC Patient Questionnaire Total score 2 years	18.56 units on a scale Standard Deviation 20.93	13.60 units on a scale Standard Deviation 17.32
WOMAC Patient Questionnaire Total score 5 years	14.44 units on a scale Standard Deviation 15.92	12.24 units on a scale Standard Deviation 16.52

SECONDARY outcome

Timeframe: pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up

Population: Because some patients missed to attend some visits as well as early termination cases, the numbers in some follow-ups differ from number analyzed.

The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D descriptive system comprises the following five dimensions: mobility self care, usual activities, pain/comfort and anxiety/depression. Each dimension has 3 levels indicating no problems, some problems or extreme problems. The index values on a scale between -1 (low) and 1 (high) are showing the average health status according to the 5 dimensions: A low score shows worse health and a high score shows better health.

Outcome measures

Outcome measures
Measure	Scorpio PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 Participants Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire Pre-operative EQ-5D	0.60 units on a scale Standard Deviation 0.21	0.53 units on a scale Standard Deviation 0.25
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire 12 weeks EQ-5D	0.76 units on a scale Standard Deviation 0.16	0.77 units on a scale Standard Deviation 0.19
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire 26 weeks EQ-5D	0.76 units on a scale Standard Deviation 0.20	0.78 units on a scale Standard Deviation 0.22
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire 1 year EQ-5D	0.72 units on a scale Standard Deviation 0.32	0.82 units on a scale Standard Deviation 0.19
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire 2 years EQ-5D	0.76 units on a scale Standard Deviation 0.28	0.81 units on a scale Standard Deviation 0.24
EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire 5 years EQ-5D	0.77 units on a scale Standard Deviation 0.26	0.80 units on a scale Standard Deviation 0.23

Adverse Events

Scorpio PS

Serious events: 10 serious events

Other events: 0 other events

Deaths: 1 deaths

Scorpio NRG PS

Serious events: 13 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Britta von den Brincken, Clinical Study Manager

Stryker

Phone: +491638999202

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Scorpio PS n=42 participants at risk Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio PS Total Knee Replacement. Scorpio PS (posterior stable): Implantation of total knee prosthesis	Scorpio NRG PS n=42 participants at risk Patients on the waiting list for a total knee prosthesis who fulfil the inclusion and exclusion criteria will be asked to participate in this study and are randomized to receive the Scorpio NRG PS Total Knee Replacement. Scorpio NRG PS: Implantation of total knee prosthesis
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharinx Carcinoma	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Cancer	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Cardiac disorders Cardiac Complaints	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Cardiac disorders Cardiac Collapse	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Cardiac disorders Myocardial Infarction	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Infections and infestations Urinary Tract Infection	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Injury, poisoning and procedural complications Wound Leakage	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Arthroscopic Nettoyage of Knee	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Injury, poisoning and procedural complications Tooth Implant Fracture	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Injury, poisoning and procedural complications Abdominal Corpus Alienum	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Knee pain insert revision	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Hip Fracture	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Tibial Component Revision	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Flexion Contracture	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Peri Articular Ossification of Hip	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Reproductive system and breast disorders Prostate Resection	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Vascular disorders Aneurism	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Vascular disorders Cerebral Infarction	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Vascular disorders Pulmonary Embolism	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Placement of patella prosthesis	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.
Musculoskeletal and connective tissue disorders Patella resurfacing	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.	0.00% 0/42 • Adverse events were collected from the time point of the study related surgery until termination from study latest at the 5 years follow-up. Definitions do not differ.