Meniscus TearNCT06749431
Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery
An observational study of Meniscus Tear and Meniscus Disorder, run by Joint Restoration Foundation, Inc. at 1 site in United States.
Trial summary
The MERCuRE (MEniscus, REstoration, Conservation, and Repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision Meniscal Allograft Transplantation surgery This clinical investigation is a prospective, primary… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Meniscus Tear, Meniscus Disorder, Patient Satisfaction
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2025to 5 Jan 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with meniscal deficiency
Who may be able to join
- Subjects enrolled in this study must meet all of the following inclusion criteria:
- Males and females aged 10-65 years
- MRI or arthroscopic images confirming the suitability for meniscus transplantation.
- Patients undergoing an isolated primary/revision MAT (meniscal allograft transplant) procedure, or concomitant MAT with other knee procedures such as ligament reconstruction, realignment osteotomy, or cartilage resurfacing.
- Medically suitable for meniscus transplantation.
- Appropriate understanding of the language of the surgical center in terms of communication and reading.
- Ability of the Patient or parent/guardian to provide informed consent.
Who cannot join
- Inability to comply with rehabilitation programs.
- Patient aged less than 10 years and more than 65.
- Presence of diffuse full thickness cartilage loss (widespread ICRS Grade III-IV chondral damage) and/or architectural remodeling of bone (i.e. flattening of condyle) in the knee of interest.
- Significant medical comorbidities that limit patients from undergoing surgery.
- Presence of confounding neuromuscular, genetic/congenital, or post-traumatic conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MERCuRE (MEniscus, Restoration, Conservation, and Repair) Group Study on Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery
The MERCuRE (MEniscus, REstoration, Conservation, and Repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision Meniscal Allograft Transplantation surgery This clinical investigation is a prospective, primary observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on patients
- Conditions
- Meniscus Tear, Meniscus Disorder, Patient Satisfaction
- Keywords
- Meniscal Allograft Transplant
- Medical subject headings
- Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score
Evaluation of knee symptoms and function, reported on a scales from 0 to 100 where 0 represents extreme knee problems and 100 represents no knee problems.
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Evaluation of PROM: Marx activity rating scale for patients > 18 years old
Measure of activities associated with high level knee function within the last year, scored from 0 to 16 where 0 is activities less than one time in a month and 16 is activities 4 or more times in a week.
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old
Measure of activity within the last month, scored from 0-30 where 0 is participating in activities less than one time per month and 16 is participating in activities more than 4 times per week.
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score
Measure of health-related quality of life for meniscus symptoms, scored from 0 to 100 where 0 is no physical symptoms or emotional feeling and 100 is extreme symptoms and extreme emotional feeling.
Measured: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Clinical Success
Data on failure defined as removal of the whole or large portion of the graft (total or subtotal meniscectomy or a large irreparable radial tear), conversion to arthroplasty or revision of the meniscal transplant.
Measured: Through study completion, up to 20 years post-operatively.
Serial Imaging: Radiographs
Knee radiographs to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
Measured: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Serial Imaging: Ultrasound
Knee ultrasound to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
Measured: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Serial Imaging: Magnetic Resonance Imaging (MRI)
Knee MRI to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
Measured: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Secondary outcomes (1)
Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs)
To define the Minimal Clinically Important Difference (MCID) for the above mentioned PRO's in these patients, and to correlate patients' demographics and surgical status of the knee, to the MCID.
Measured: Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start5 Jan 2025 (estimated)
- Primary completion5 Jan 2030 (estimated)
- Study completion5 Jan 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Joint Restoration Foundation, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749431
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MERCuRE (MEniscus, Restoration, Conservation, and Repair) Group Study on Clinical Outcomes, Graft Longevity, and Chondral Protection Following Primary or Revision Meniscal Allograft Transplantation Surgery
- ClinicalTrials.gov ID
- NCT06749431
- Acronym / sponsor ID
- 001
- Conditions
- Meniscus Tear, Meniscus Disorder, Patient Satisfaction
- Keywords
- Meniscal Allograft Transplant
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Joint Restoration Foundation, Inc.University, hospital or other
- Study start
- 5 Jan 2025 (estimated)
- Primary completion
- 5 Jan 2030 (estimated)
- Study completion
- 5 Jan 2050 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MERCuRE (MEniscus, REstoration, Conservation, and Repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision Meniscal Allograft Transplantation surgery This clinical investigation is a prospective, primary observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with meniscal deficiency
Key inclusion criteria (7 listed)
- Males and females aged 10-65 years
- MRI or arthroscopic images confirming the suitability for meniscus transplantation.
- Patients undergoing an isolated primary/revision MAT (meniscal allograft transplant) procedure, or concomitant MAT with other knee procedures such as ligament reconstruction, realignment osteotomy, or cartilage resurfacing.
- Medically suitable for meniscus transplantation.
- Appropriate understanding of the language of the surgical center in terms of communication and reading.
Key exclusion criteria (5 listed)
- Inability to comply with rehabilitation programs.
- Patient aged less than 10 years and more than 65.
- Presence of diffuse full thickness cartilage loss (widespread ICRS Grade III-IV chondral damage) and/or architectural remodeling of bone (i.e. flattening of condyle) in the knee of interest.
- Significant medical comorbidities that limit patients from undergoing surgery.
- Presence of confounding neuromuscular, genetic/congenital, or post-traumatic conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Evaluation of knee symptoms and function, reported on a scales from 0 to 100 where 0 represents extreme knee problems and 100 represents no knee problems.
Evaluation of PROM: Marx activity rating scale for patients > 18 years old
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Measure of activities associated with high level knee function within the last year, scored from 0 to 16 where 0 is activities less than one time in a month and 16 is activities 4 or more times in a week.
Evaluation of PROM: Pediatric Functional Activity Brief Scale (Pedi-FABS) score for patients 10-18 years old
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Measure of activity within the last month, scored from 0-30 where 0 is participating in activities less than one time per month and 16 is participating in activities more than 4 times per week.
Evaluation of PROM: Western Ontario Meniscal Evaluation Tool (WOMET) score
Time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Measure of health-related quality of life for meniscus symptoms, scored from 0 to 100 where 0 is no physical symptoms or emotional feeling and 100 is extreme symptoms and extreme emotional feeling.
Clinical Success
Time frame: Through study completion, up to 20 years post-operatively.
Data on failure defined as removal of the whole or large portion of the graft (total or subtotal meniscectomy or a large irreparable radial tear), conversion to arthroplasty or revision of the meniscal transplant.
Serial Imaging: Radiographs
Time frame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Knee radiographs to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
Serial Imaging: Ultrasound
Time frame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Knee ultrasound to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
Serial Imaging: Magnetic Resonance Imaging (MRI)
Time frame: baseline (pre-op), 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively
Knee MRI to determine graft longevity, status/presence of extrusion and the post-operative chondral status of the knee.
1 secondary outcome
Minimal Clinically Important Difference (MCID) in Patient Reported Outcomes (PROs)
Time frame: Calculated by anchor question response pre-operatively, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Tear and Meniscus Disorder, run by Joint Restoration Foundation, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of PROM: The Knee Injury and Osteoarthritis Outcome (KOOS) Score (time frame: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years, 15 years, and 20 years post-operatively). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.