Clinical Application of BioCleanse Meniscus
- Conditions
- Tear of Meniscus of Knee
- Registration Number
- NCT00659880
- Lead Sponsor
- RTI Surgical
- Brief Summary
This study will follow patients after routine surgery of a meniscal allograft transplant.
- Detailed Description
The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
- All patients, up to 10 who have selected a BioCleanse Meniscus transplant
- Anyone not eligible for a meniscal transplant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Knee Injury and Osteoarthritis Outcome Score (KOOS) 60 months The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.
- Secondary Outcome Measures
Name Time Method MRI Assessments 12 months MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.
Images were also assessed for oedema in each of these 3 regions of the meniscus.
Trial Locations
- Locations (1)
OrthoIndy
🇺🇸Indianapolis, Indiana, United States