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

Phase 4

Completed

• Conditions: Knee Arthroplasty, Total; Arthroplasty, Replacement, Knee
• Interventions: Device: SCORPIO™

• Registration Number: NCT02429856
• Lead Sponsor: University of Alberta

Brief Summary

This randomized clinical trial (RCT) examined 10 year outcomes comparing SCORPIO™ Posterior Cruciate Substituting (PCS) versus Posterior Cruciate Retaining (PCR) Total Knee Arthroplasty (TKA) as the primary outcome.

Detailed Description

RCT of 100 subjects undergoing primary TKA who were randomized to received either a SCORPIO™ PCS or PCR TKA.

Subjects were evaluated pre-operatively and at 2 and 10 years post-operatively using the Western Ontario (WOMAC) Osteoarthritis Index, the RAND-36 and knee range of motion (2 years only). Complication and revision rates were also evaluated.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Results First Submitted: 2016-12-12
• Results First Submitted QC: 2019-05-10
• Results First Posted: 2019-05-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• scheduled for primary TKA
• non-inflammatory arthritis
• intact Posterior Cruciate Ligament at the time of surgery

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Exclusion Criteria

• required bone grafting of either the femur or tibia
• varus or valgus deformity of > 15 degrees
• previous high tibial osteotomy
• unable to understand or comply with the study requirements
• unable to provide signed informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCS	SCORPIO™	SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis
PCR	SCORPIO™	SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis

Primary Outcome Measures

Name	Time	Method
WOMAC Osteoarthritis Index Function	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
Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain	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

Secondary Outcome Measures

Name	Time	Method
RAND -36 Health Survey	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.
Number of Complications	within 10 years of surgery
Revision Rate	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
Knee Range of Motion	knee ROM at 2 years postoperative	Knee Range of Motion measured as a calculated total of knee flexion + knee extension; measured in degrees

Trial Locations

Locations (1)

Alberta Health Services - Edmonton zone; 🇨🇦 Edmonton, Alberta, Canada