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Clinical Trials/NCT00380861
NCT00380861CompletedNot Applicable

Does Implant Design Improve Postoperative Flexion?A Prospective, Randomized, Comparative, Multi-center Study Comparing PFC® Sigma™ RP Knee Versus PFC® Sigma™ RP-F Implanted in Simultaneous Bilateral Subjects

DePuy Orthopaedics8 sites in 1 country93 target enrollmentStarted: March 1, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
93
Locations
8
Primary Endpoint
Knee Society Passive Flexion at 6 Months
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study will evaluate whether design features of one implant design allows more knee bend than the other. Patients will have 1 design in the left knee and 1 design in their right knee. Both knee surgeries will be on the same day.

Detailed Description

The primary objective of this study is to determine whether the passive, non-weight-bearing flexion is superior with the posterior-stabilized PFC® Sigma™ RP-F compared to the posterior-stabilized PFC® Sigma™ RP in bilateral Subjects receiving both implants and if this difference is a function of implant design.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Non-Inflammatory Arthritis
  • •Age = 40-70 years
  • •Male or female
  • •Suitable for devices in study
  • •Needing primary simultaneous bilateral knee replacements
  • •Willing to consent and authorize release of personal health information
  • •Subjects who are able to understand this clinical investigation, co-operate with investigational procedures and are willing to return to the clinic, hospital and predefined physical therapy centers for all the required postoperative follow-ups,

Exclusion Criteria

  • •Existing conditions that would compromise participation
  • •Multiple joint involvement
  • •Pregnant/lactating women
  • •Inflammatory arthritis
  • •Fixed flexion contracture greater than 20 degrees
  • •Previous knee replacement of any type
  • •Needing device(s) not specified in protocol
  • •The Subject is a known drug or alcohol abuser or has a psychological disorder that would compromise follow-up
  • •Those who have participated in an investigation in the last 3 months
  • •Those involved in personal injury litigation, medical-legal or workers compensation claims
  • •Failure to follow surgical technique details specified in the protocol

Outcomes

Primary Outcomes

Knee Society Passive Flexion at 6 Months

Time Frame: 6 months

The patient lies supine (on their back) on the table and a medically trained professional moves the limb to bend the knee to a maximum flexion position. The angle of flexion is measured with a goniometer, which is an angle-measuring device.

Secondary Outcomes

  • Subgroup Analysis - Passive Flexion Analyzed and Reported for Pre-op, 6- and 12-months, for Subjects With Less Than 120 Degrees Passive Flexion Pre-op in Either Knee(Collected at Pre-operative, 2 and 6 weeks and 6- and 12-months, analyzed and reported for pre-op, 6- and 12-months)
  • Patient Specific Anthropometrics(Collected at pre-op)
  • Ability to Perform Activities of Daily Living (ADLs) as Per the KOOS Sub-scale for ADLs(Collected at pre-operative, 2 and 6 weeks and 6 and 12 months, analyzed and reported for pre-op, 6 and 12-months)
  • Single Leg Active Flexion (SLAF)(Pre-op, 6- and 12-months)
  • American Knee Society (AKS) Score(Collected Pre-operative, 2 and 6 weeks and 6 and 12 months follow up. Reporting for final 12-month interval)
  • KOOS Pain Sub-score(Pre-operative, 2 and 6 weeks and 6 and 12 months and analyzed and reported for pre-op, 6- and 12-months follow up)
  • Patellar Crepitus Defined as No Crepitus, FINE or COARSE(Collected at Pre-operative, 6 weeks and 6 and 12 months)
  • Subject Satisfaction(Collected pre-and post-op, reported at 12-months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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