Knee Injury
Conditions
Keywords
Cartilage injury, OATS, Knee injury, allograft, autograft
Brief 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.
Detailed description
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 at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).
Interventions
OTHERCR Plug
CR Plug will be placed in the harvest site
Sponsors
RTI Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI to Evaluate Success of Outcome. | 24 months | The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score. |
Countries
United States
Participant flow
Recruitment details
All participants were recruited from the patient population at the four investigative sites
Pre-assignment details
This was a single arm study, thus there is no assignment
Participants by arm
| Arm | Count |
|---|---|
| CR Plug BackFill Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | CR Plug BackFill |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 33.1 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
MRI to Evaluate Success of Outcome.
The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively. The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CR Plug BackFill | MRI to Evaluate Success of Outcome. | 88.6 units on a scale | Standard Deviation 5.7 |