Does Implant Design Improve Postoperative Flexion?

Completed · Not applicable

Conditions studied: Non-inflammatory Arthritis

In brief

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.

Key facts

Study ID

NCT00380861

Run by

DePuy Orthopaedics

People needed

93

Starts

2006-03-01

Expected to finish

2009-12-01

Last updated by the study team

2023-07-24

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,

You may not qualify if…

• 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

Where it is running

• Doug Dennis — Denver, Colorado, United States
• Heekin Orthopaedics — Jacksonville, Florida, United States
• University of Iowa Hospital & Clinic Dept. of Orthopaedic Surgery — Iowa City, Iowa, United States
• Lakewood Orthopaedic Surgeons — Lakewood, Washington, United States

Full record on ClinicalTrials.gov

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