Trials / Completed
CompletedNCT00380861
Does Implant Design Improve Postoperative Flexion?
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total knee replacement using the PFC Sigma RPF knee implant. | Total knee replacement |
| DEVICE | Total knee replacement using the PFC Sigma RP knee implant | Total knee replacement |
Timeline
- Start date
- 2006-03-01
- Primary completion
- 2009-12-01
- Completion
- 2009-12-01
- First posted
- 2006-09-27
- Last updated
- 2023-07-24
- Results posted
- 2011-04-05
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00380861. Inclusion in this directory is not an endorsement.