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Completed

NCT Number: NCT02429856

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

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.

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Key information

Conditions

Arthroplasty, Replacement, Knee Knee Arthroplasty, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alberta Health Services - Edmonton zone

Edmonton, Alberta, TG6 2B7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SCORPIO™

Device

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

Primary outcomes

  1. Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain

    Time frame: 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

  2. WOMAC Osteoarthritis Index Function

    Time frame: 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

Secondary outcomes

  1. RAND -36 Health Survey

    Time frame: 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.

  2. Revision Rate

    Time frame: 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

  3. Number of Complications

    Time frame: within 10 years of surgery

  4. Knee Range of Motion

    Time frame: knee ROM at 2 years postoperative

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: SCORPIO™

Important dates

Study start
1999
Primary completion
2013
Study completion
2013
First posted
Apr 29, 2015
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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