Knee Injury
Conditions
Keywords
allograft, knee injury, cartilage injury
Brief summary
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).
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.
Interventions
OTHERPrimary injury site
Autograft will be placed in the primary defect site.
OTHERBackfill site
Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.
Sponsors
RTI Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 55 years * skeletally mature * Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. 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 on Merchant view * One or more multiple defects greater than 2.5 cm * Osteochondritis dissecans (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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS | 24 months | The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Current Health Assessment (CHA) | 24 months | Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved. |
| IKDC Assessment | 24 months | The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score, |
| Magnetic Resonance Imaging (MRI) Results | 24 months | MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft. |
| Lysholm Score at 24 Months | 24 months | The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function. |
Countries
United States
Participant flow
Recruitment details
All participants were recruited from the patient population at one of the investigative sites between 12 June 2009 and 5 May 2010. One subject was enrolled at 17 years, 7 months. A protocol waiver was approved by the Institutional Review Board and parental informed consent and assent of subject was obtained.
Pre-assignment details
Patients were assigned to the treatment arm based on a randomization table. Enrolled patients excluded: Not fulfilling inclusion or exclusion criteria, withdrawal of consent. Enrolled patients were followed to completion unless lost to follow up. Of 4 enrolled, 1 withdrew consent, 1 was lost to follow up & 2 completed
Participants by arm
| Arm | Count |
|---|---|
| Backfill Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site | 2 |
| Primary CR Plug will be placed in the site of the primary injury | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Primary | Backfill | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Continuous | 17 years STANDARD_DEVIATION 0 | 28.5 years STANDARD_DEVIATION 12.02 | 24.7 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 1 participants | 2 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 2 | 1 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS
The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time frame: 24 months
Population: Of the 2 patients enrolled in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Backfill | Knee Injury and Osteoarthritis Outcome Score (KOOS | 82.74 units on a scale |
| Primary | Knee Injury and Osteoarthritis Outcome Score (KOOS | 100 units on a scale |
Secondary
Current Health Assessment (CHA)
Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.
Time frame: 24 months
Population: Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Backfill | Current Health Assessment (CHA) | 80.6 units on a scale |
| Primary | Current Health Assessment (CHA) | 100 units on a scale |
Secondary
IKDC Assessment
The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,
Time frame: 24 months
Population: Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Backfill | IKDC Assessment | 74.7 units on a scale |
| Primary | IKDC Assessment | 98.6 units on a scale |
Secondary
Lysholm Score at 24 Months
The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
Time frame: 24 months
Population: Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Backfill | Lysholm Score at 24 Months | 81 units on a scale |
| Primary | Lysholm Score at 24 Months | 100 units on a scale |
Secondary
Magnetic Resonance Imaging (MRI) Results
MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.
Time frame: 24 months
Population: Of the 2 patients enrolled in the study in the backfill group, 1 was lost to follow-up, therefore the data presented is for only 1 patient.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Backfill | Magnetic Resonance Imaging (MRI) Results | 97.1 units on a scale |
| Primary | Magnetic Resonance Imaging (MRI) Results | 100 units on a scale |