OsteoarthritisNCT02319811
Cryopreserved Human Meniscus Transplantation
An observational study of Osteoarthritis, run by Cincinnati Sportsmedicine Research and Education Foundation.
Trial summary
The purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes. Read more about this study
- Who is it for?
- Ages 14 to 49 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Cryopreserved meniscus transplants
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- Nov 1995to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Minimum age: 14 Years Maximum age: 49 Years Gender: Both Accepts Healthy Volunteers: No Patients post-meniscectomy, symptomatic with activities, early cartilage degeneration in affected tibiofemoral compartment.
Who may be able to join
- Patient post-meniscectomy
- Patient symptomatic with activities
- Patient has early articular cartilage degeneration in affected tibiofemoral compartment
- Patient understands goals of operation, willing to undergo lengthy rehabilitation
Who cannot join
- Patient has no symptoms with activities
- Patient has advanced degeneration in affected tibiofemoral compartment or other compartments
- Patient is obese (BMI > 30)
- Patient has uncorrected lower limb axial malalignment or knee ligament deficiency
- Patient has active infection
- Patient has pre-existing knee arthrofibrosis or lower limb muscular atrophy
- Patient has symptomatic patellofemoral articular cartilage deterioration
- Patient is unwilling to undergo lengthy rehabilitation after surgery
About this study
Official title: Meniscus Transplantation in Symptomatic Patients Under Fifty Years of Age: Survivorship Analysis
The purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.
Read the detailed description
All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10, and 15 years postoperatively. Study examination will include comprehensive knee examination by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and Occupational Rating Form. All patient identification will be kept confidential. Patient data will be entered into the Knee Registry database according to their unique study number by the clinical research assistant.
- Conditions
- Osteoarthritis
- Being tested
- Cryopreserved meniscus transplants
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved meniscus transplantsProcedure or surgery
Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.
| Study group | Role | What they receive |
|---|---|---|
| Cryopreserved meniscus transplant | Intervention: Lateral or medial cryopreserved meniscus transplant implanted into appropriately indicated patients. Receives: Procedure: Cryopreserved meniscus transplants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship analysis
Measured: 15 years postoperatively
Secondary outcomes (2)
Cincinnati Knee Rating System
The following factors will be scored according to the validated Cincinnati Knee Rating System: pain, swelling, giving-way, walking, stair-climbing, squatting, running, jumping, pivoting, sports activity level, occupational level, patient perception of the knee condition.
Measured: 15 years postoperatively
International Knee Documentations Committee
The validated IKDC overall evaluation form will be used to rate knee function.
Measured: 15 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startNov 1995
- Primary completionDec 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank R Noyes, M.D., Principal investigator, President, Noyes Knee Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319811
- Sponsor's protocol ID
- MenisCryo-001
- Status last verified
- Apr 2016
- First submitted
- 10 Dec 2014
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Published results in Journal of Bone and Joint Surgery, 2015 and American Journal of Sports Medicine 2016
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meniscus Transplantation in Symptomatic Patients Under Fifty Years of Age: Survivorship Analysis
- ClinicalTrials.gov ID
- NCT02319811
- Acronym / sponsor ID
- MenisCryo-001
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education FoundationUniversity, hospital or other
- Study start
- Nov 1995
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Dec 2014 (estimated)
- 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 purpose of this study is to determine the long-term survivorship and clinical outcomes of all cryopreserved meniscus transplants performed by Dr. Frank Noyes.
Detailed description
All patients receiving cryopreserved meniscus transplants will be followed at 1, 2, 5, 10, and 15 years postoperatively. Study examination will include comprehensive knee examination by Dr. Noyes, x-rays, and potentially MRI. Patients will complete the following forms of the Cincinnati Knee Rating System: Symptom Rating Form, Sports Activity and Function Form, and Occupational Rating Form. All patient identification will be kept confidential. Patient data will be entered into the Knee Registry database according to their unique study number by the clinical research assistant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryopreserved meniscus transplant | – | Procedure: Cryopreserved meniscus transplantsIntervention: Lateral or medial cryopreserved meniscus transplant implanted into appropriately indicated patients. |
Who may qualify
- Ages
- 14 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Minimum age: 14 Years Maximum age: 49 Years Gender: Both Accepts Healthy Volunteers: No Patients post-meniscectomy, symptomatic with activities, early cartilage degeneration in affected tibiofemoral compartment.
Key inclusion criteria (4 listed)
- Patient post-meniscectomy
- Patient symptomatic with activities
- Patient has early articular cartilage degeneration in affected tibiofemoral compartment
- Patient understands goals of operation, willing to undergo lengthy rehabilitation
Key exclusion criteria (8 listed)
- Patient has no symptoms with activities
- Patient has advanced degeneration in affected tibiofemoral compartment or other compartments
- Patient is obese (BMI > 30)
- Patient has uncorrected lower limb axial malalignment or knee ligament deficiency
- Patient has active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved meniscus transplantsLateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients. | Procedure or surgery | Cryopreserved meniscus transplant |
Primary outcome
Survivorship analysis
Time frame: 15 years postoperatively
2 secondary outcomes
Cincinnati Knee Rating System
Time frame: 15 years postoperatively
International Knee Documentations Committee
Time frame: 15 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Individual participant dataSharing planned: Yes. Published results in Journal of Bone and Joint Surgery, 2015 and American Journal of Sports Medicine 2016
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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. This study is not recruiting at the moment.
Frank R Noyes, M.D. principal investigator
President, Noyes Knee Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by Cincinnati Sportsmedicine Research and Education Foundation.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survivorship analysis (time frame: 15 years postoperatively). 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 13 Apr 2016; AzTrials last refreshed its copy on 30 Oct 2026.