Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-03-08 @ 12:16 AM
Study NCT ID:
NCT02429856
Status:
COMPLETED
Last Update Posted:
2021-07-27
First Post:
2015-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Posterior Cruciate Retaining (PCR) Versus Posterior Cruciate Substituting (PCS) Total Knee Arthroplasty (TKA)
Sponsor:
University of Alberta
Organization:
Study Overview
Official Title:
SCORPIO™ Posterior Stabilized Versus Posterior Retained Total Knee Arthroplasties: Long-term Functional and Radiographic Outcome
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCORPIO™
Brief 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.
Detailed 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: