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

NCT ID: NCT02429856

Last Updated: 2021-07-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-02-28

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Arthroplasty, Replacement, Knee Knee Arthroplasty, Total

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PCS

SCORPIO™ Posterior Cruciate Ligament Substituting TKA prosthesis

Group Type ACTIVE_COMPARATOR

SCORPIO™

Intervention Type DEVICE

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

PCR

SCORPIO™ Posterior Cruciate Ligament Retaining TKA prosthesis

Group Type ACTIVE_COMPARATOR

SCORPIO™

Intervention Type DEVICE

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

Interventions

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SCORPIO™

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alberta Health Services - Edmonton zone

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Chaudhary R, Beaupre 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):2579-86. doi: 10.2106/JBJS.G.00995.

Reference Type RESULT
PMID: 19047702 (View on PubMed)

Other Identifiers

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Pro00002407

Identifier Type: -

Identifier Source: org_study_id

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