Tear of Meniscus of Knee
Conditions
Keywords
Meniscus transplant, Meniscal allograft, MAT, Knee
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.
Interventions
OTHERBioCleanse Meniscus
Subjects will undergo routine meniscal allograft transplant surgery.
Sponsors
RTI Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* All patients, up to 10 who have selected a BioCleanse Meniscus transplant
Exclusion criteria
* Anyone not eligible for a meniscal transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meniscal Allograft Transplant Patients who received a BioCeanse Meniscal Allograft Transplant | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Meniscal Allograft Transplant |
|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 7.6 |
| 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 | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.
Time frame: 60 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meniscal Allograft Transplant | Knee Injury and Osteoarthritis Outcome Score (KOOS) | 70.1 units on a scale | Standard Deviation 33.6 |
p-value: 0.06Friedman
Secondary
MRI Assessments
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Meniscal Allograft Transplant | MRI Assessments | Integration of Meniscal Body | 4 participants |
| Meniscal Allograft Transplant | MRI Assessments | Integration of Anterior Horn | 3 participants |
| Meniscal Allograft Transplant | MRI Assessments | Integration of Posterior Horn | 4 participants |
| Meniscal Allograft Transplant | MRI Assessments | Mild Edema Anterior Horn | 2 participants |
| Meniscal Allograft Transplant | MRI Assessments | Mild Edema Posterior Horn | 1 participants |
| Meniscal Allograft Transplant | MRI Assessments | Mild Edema Meniscal Body | 0 participants |