Trial record 8 of 301 for:
knee injuries
Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in the Knee
This study is ongoing, but not recruiting participants.
Sponsor:
RTI Biologics
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00984594
First received: September 24, 2009
Last updated: May 2, 2012
Last verified: May 2012
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Purpose
The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment of smaller, focal defects (like the injury the patient has to their knee).
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Injury |
Other: Primary injury site Other: Backfill site |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle |
Resource links provided by NLM:
Further study details as provided by RTI Biologics:
Primary Outcome Measures:
- Decrease in preoperative pain as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement in quality of life scores [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- KOOS [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Improvement in Lysholm with Tegner [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- International Knee Documentation Committee (IKDC) assessment forms [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- IKDC objective evaluation [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
- Magnetic Resonance Imaging (MRI) results [ Time Frame: 3, 6, 12, 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Primary injury site
CR Plug will be placed in the primary injury site.
|
Other: Primary injury site
Place CR Plug in primary injury site
|
|
Backfill site
CR Plug will be placed in site that autograft was harvest for be placed in primary injury site
|
Other: Backfill site
CR Plug will be placed in site of autograft that will then be placed in the primary injury site
|
Detailed Description:
The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18 to 55 years
- skeletally mature
- Have a symptomatic score ICRS grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the MFC or LFC. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
- Functional meniscal tissue (defined as 5 mmor greater)
- A score of = or greater than 4 on the VAS questionnaire
Exclusion Criteria:
- Associated tibial or patellar articular cartilage defect greater than 2 ICRS
- Osteoarthritis of either knee
- Mechanical axis malalignment of greater than 5 degrees
- Patellofemoral incongruity of Merchant view
- One or more multiple defects greater than 2.5 cm
- Osteochondritis dessecans (OCD) with depth of bone loss greater than 4 mm
- Ligament treatments in the affected knee within one year prior to current study
- Previous surgical meniscus treatment in the affected knee in the last 6 months
- Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
- use of any investigational therapy within 30 days prior to the first visit
- Corticosteroid or viscosupplementation within the past 3 months
- A score of 3 or less on the VAS questionnaire
- Active gout or pseudogout or systemic inflammatory condition
- Microfracture less than one year prior to current study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984594
Locations
| United States, Kentucky | |
| Ellis and Badenhausen Orthopaedics, PSC | |
| Louisville, Kentucky, United States, 40202 | |
Sponsors and Collaborators
RTI Biologics
Investigators
| Principal Investigator: | Akbar Nawab, MD | Ellis and Badenhausen Orthopaedics, PSC |
More Information
No publications provided
| Responsible Party: | RTI Biologics |
| ClinicalTrials.gov Identifier: | NCT00984594 History of Changes |
| Other Study ID Numbers: | CR2008 |
| Study First Received: | September 24, 2009 |
| Last Updated: | May 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by RTI Biologics:
|
allograft knee injury cartilage injury |
Additional relevant MeSH terms:
|
Knee Injuries Leg Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013