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

SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Knee Arthroplasty, Total
• Intervention / Treatment: Device: SCORPIO™

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, TG6 2B7
      • Alberta Health Services - Edmonton zone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCS; SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis	Device: SCORPIO™; subjects randomized at surgery to receive 1 of the 2 specified implants
Active Comparator: PCR; SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis	Device: SCORPIO™; subjects randomized at surgery to receive 1 of the 2 specified implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain	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	10 years postoperative
WOMAC Osteoarthritis Index Function	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	10 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alberta

Publications and helpful links

General Publications

• Chaudhary R, Beaupre LA, Johnston DW. Knee range of motion during the first two years after use of posterior cruciate-stabilizing or posterior cruciate-retaining total knee prostheses. A randomized clinical trial. J Bone Joint Surg Am. 2008 Dec;90(12):2579-86. doi: 10.2106/JBJS.G.00995.

Study record dates

Study Major Dates

• Study Start: February 1, 1999
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 17, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00002407