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

Arthroplasty, Replacement, Knee Clinical Trial

— SCORPIO™  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429856
• Other study ID #: Pro00002407
• Status: Completed
• Phase: Phase 4
• Start date: February 1999
• Est. completion date: May 2013

Study information

• Verified date: July 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Knee Arthroplasty, Total

Intervention

Device:
• SCORPIO™
subjects randomized at surgery to receive 1 of the 2 specified implants

Locations

Country	Name	City	State
Canada	Alberta Health Services - Edmonton zone	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Chaudhary R, Beaupré 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):257 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Number of Complications		within 10 years of surgery
Secondary	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