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

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Arthroplasty, Replacement, Knee; Knee Arthroplasty, Total

Treatments: Device: SCORPIO™

Study type: Interventional

Funder types: Other

Identifiers

NCT02429856

Pro00002407

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

PCS

Active Comparator group

Description:

SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis

Treatment:

Device: SCORPIO™

PCR

Active Comparator group

Description:

SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis

Treatment:

Device: SCORPIO™