Phase 3
N=9
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.
Knee Injury
Bottom Line
View on ClinicalTrials.gov: NCT00821873 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: MRI to Evaluate Success of Outcome. — 88.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CR Plug (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- RTI Surgical
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI to Evaluate Success of Outcome. |
88.6 | — |
Summary
The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.
Eligibility Criteria
Inclusion Criteria
- Are male or female at least 18 years of age and up to 55 years of age
- Must be skeletally mature
- Have a grade III or IV lesion in femoral condyle
Exclusion Criteria
- Skeletally immature
- Osteoarthritic knees, osteonecrotic knees, osteophyte formation
- Use of any investigational therapy within thirty (30) days prior to the first visit
Data sourced from ClinicalTrials.gov (NCT00821873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.