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

University of Alberta100 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Arthroplasty, Replacement, Knee Knee Arthroplasty, Total

Interventions

SCORPIO™DEVICE

subjects randomized at surgery to receive 1 of the 2 specified implants

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Alberta Health Services - Edmonton zone

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

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

Time frame: 10 years postoperative

WOMAC Osteoarthritis Index Function

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 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

Time frame: within 10 years of surgery

Number of Complications

Time frame: 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

Time frame: knee ROM at 2 years postoperative

Data from ClinicalTrials.gov

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