Trials / Completed
CompletedNCT00733499
A Study to Determine the Difference in Low Contact Stress (LCS) Duofix Versus Low LCS Porocoat Knee Systems
A Prospective, Randomised, Single Blinded Study Comparing the Pain, Biological Fixation and Outcomes of Patients With LCS Complete Duofix or LCS Porocoat Knee Systems
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 206 (actual)
- Sponsor
- DePuy International · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this investigation is to test the hypothesis that the Duofix Tibial component results in a reduction of immediate postoperative pain compared to the LCS Porocoat version.
Detailed description
The secondary objectives of this investigation are to evaluate the clinical and patient outcomes, biological fixation and survivorship associated with the LCS Duofix and Porocoat knee system over 10 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LCS Complete Duofix | Orthopaedic implant for total knee replacement with Duofix biological fixation surfaces |
| DEVICE | LCS Complete Porocoat | Orthopaedic implant for total knee replacement with Porocoat biological fixation surfaces |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2009-10-01
- Completion
- 2018-10-22
- First posted
- 2008-08-13
- Last updated
- 2020-01-14
- Results posted
- 2014-08-04
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT00733499. Inclusion in this directory is not an endorsement.