Phase 4 N=100 Randomized Double-blind Treatment

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

Arthroplasty, Replacement, Knee · Knee Arthroplasty, Total

Bottom Line

View on ClinicalTrials.gov: NCT02429856 ↗

Enrolled (actual)

100

Serious AEs

7.0%

Results posted

May 2019

Primary outcome: Primary: Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain — 84.0; 78.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: SCORPIO™ (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Western Ontario McMaster (WOMAC) Osteoarthritis Index Pain	84.0; 78.3	—
PRIMARY WOMAC Osteoarthritis Index Function	67.9; 72.7	—
SECONDARY RAND -36 Health Survey	42.4; 50.3	—
SECONDARY Revision Rate	5; 2	—
SECONDARY Number of Complications	6; 2	—
SECONDARY Knee Range of Motion	105.8; 105.9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02429856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.