Trial Outcomes & Findings for Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA) (NCT NCT02429856)

Results Overview

disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

10 years postoperative

Results posted on

2021-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	PCS Group SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants
Overall Study STARTED	49	51
Overall Study COMPLETED	30	32
Overall Study NOT COMPLETED	19	19

Reasons for withdrawal

Reasons for withdrawal
Measure	PCS Group SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants
Overall Study Death	12	13
Overall Study Lost to Follow-up	6	5
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCS Group n=49 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants	PCR Group n=51 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified implants	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	49 Participants n=93 Participants	51 Participants n=4 Participants	100 Participants n=27 Participants
Age, Continuous	70.2 years STANDARD_DEVIATION 8.4 • n=93 Participants	69.2 years STANDARD_DEVIATION 9.1 • n=4 Participants	69.7 years STANDARD_DEVIATION 8.6 • n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	27 Participants n=4 Participants	49 Participants n=27 Participants
Sex: Female, Male Male	27 Participants n=93 Participants	24 Participants n=4 Participants	51 Participants n=27 Participants
Region of Enrollment Canada	49 Participants n=93 Participants	51 Participants n=4 Participants	100 Participants n=27 Participants

PRIMARY outcome

Timeframe: 10 years postoperative

disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

Outcome measures

Outcome measures
Measure	PCS Group n=30 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=32 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain	84.0 units on a scale Standard Deviation 19.8	78.3 units on a scale Standard Deviation 24.5

PRIMARY outcome

Timeframe: 10 years

disease-specific patient reported health related quality of life (pain and function) with 2 constructs (pain; function) each ranging from 0-100 points No total score is calculated; we report the WOMAC in reverse order to align with the RAND-36 scores where higher scores are considered better than lower scores

Outcome measures

Outcome measures
Measure	PCS Group n=26 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=30 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
WOMAC Osteoarthritis Index Function	67.9 units on a scale Standard Deviation 25.6	72.7 units on a scale Standard Deviation 23.3

SECONDARY outcome

Timeframe: 10 years postoperative

generic patient reported health related quality of life measure with 8 dimensions of health - we report the physical function dimension only with scores ranging from 0-100 where higher scores indicate better physical function.

Outcome measures

Outcome measures
Measure	PCS Group n=30 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=32 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
RAND -36 Health Survey	42.4 units on a scale Standard Deviation 28.7	50.3 units on a scale Standard Deviation 29.3

SECONDARY outcome

Timeframe: within 10 years of surgery

number of participants with revision surgery (ie another surgery on the same knee) for any cause data obtained from patient report and regional administrative databases

Outcome measures

Outcome measures
Measure	PCS Group n=30 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=32 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Revision Rate	5 Participants	2 Participants

SECONDARY outcome

Timeframe: within 10 years of surgery

Population: These complications include the revisions already recorded.

Outcome measures

Outcome measures
Measure	PCS Group n=32 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=30 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Number of Complications	6 Participants	2 Participants

SECONDARY outcome

Timeframe: knee ROM at 2 years postoperative

Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees

Outcome measures

Outcome measures
Measure	PCS Group n=38 Participants SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=40 Participants SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Knee Range of Motion	105.8 degrees Standard Deviation 13.5	105.9 degrees Standard Deviation 13.0

Adverse Events

PCS Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

PCR Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PCS Group n=49 participants at risk SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants	PCR Group n=51 participants at risk SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis SCORPIO™: subjects randomized at surgery to receive 1 of the 2 specified TKA implants
Musculoskeletal and connective tissue disorders Revision of TKA	10.2% 5/49 • Number of events 5	3.9% 2/51 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Director of NACTRC

UAlberta

Phone: 780-407-8007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place