Meniscectomy SequelaeERAMNCT01059409
Study of Meniscal Allografts
A study testing Meniscal Allograft in people with Meniscectomy Sequelae, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscectomy Sequelae
- What is being tested?
- Meniscal Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2010to 30 Sep 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 on
- Previous total or subtotal meniscectomy
- Medical insurance
- Female patients have to be under contraceptive treatment
- Sign consent form
Who cannot join
- Age < 18 years
- Pregnant or breast-feeding woman
- Need of a simultaneous frontal osteotomy
- Inflammatory disease
- Septic background
- Psychiatric background
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- Understanding difficulties or problems for follow-up
- No consent
- No medical insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Avicenne - Service de Chirurgie orthopédique
Bobigny, Île-de-France Region, 93009
POTEL Jean-François, Clinique Medipole Garonne
Toulouse, 31036
About this study
Official title: The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.
Read the detailed description
Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.
The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.
The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.
- Conditions
- Meniscectomy Sequelae
- Being tested
- Meniscal Allograft
- Keywords
- Meniscal Allografts, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meniscal AllograftProcedure or surgery
Meniscal Allograft
| Study group | Role | What they receive |
|---|---|---|
| Meniscal Allograft | Experimental | Not described Receives: Procedure: Meniscal Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Function" Subscale in the Koos Scale (area under the curve)
Koos Scale
Measured: 2 years follow up
Secondary outcomes (2)
Clinical criteria: pain, quality of life, professional activity
Pain, quality of life, professional activity
Measured: At 2 years follow-up
Post operative and late complications
Post operative complications
Measured: At 2 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startSep 2010
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Why it stopped: Insufficient number of patients included compared to the expected duration of inclusion. sponsor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscectomy SequelaeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Patricia THOREUX, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059409
- Sponsor's protocol ID
- P070309 / IC0705
- Acronym
- ERAM
- Status last verified
- Mar 2020
- First submitted
- 28 Jan 2010
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy.
- ClinicalTrials.gov ID
- NCT01059409
- Acronym / sponsor ID
- ERAM / P070309 / IC0705
- Conditions
- Meniscectomy Sequelae
- Keywords
- Meniscal Allografts, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of patients included compared to the expected duration of inclusion. sponsor's decision
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2010 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 29 Jan 2010 (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.
Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.
Detailed description
Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.
The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.
The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meniscal Allograft | Experimental | Procedure: Meniscal Allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 18 on
- Previous total or subtotal meniscectomy
- Medical insurance
- Female patients have to be under contraceptive treatment
- Sign consent form
Key exclusion criteria (9 listed)
- Age < 18 years
- Pregnant or breast-feeding woman
- Need of a simultaneous frontal osteotomy
- Inflammatory disease
- Septic background
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 |
|---|---|---|
| Meniscal AllograftMeniscal Allograft | Procedure or surgery | Meniscal Allograft |
Primary outcome
"Function" Subscale in the Koos Scale (area under the curve)
Time frame: 2 years follow up
Koos Scale
2 secondary outcomes
Clinical criteria: pain, quality of life, professional activity
Time frame: At 2 years follow-up
Post operative and late complications
Time frame: At 2 years follow-up
Results and safety
The study was stopped early (reason given: Insufficient number of patients included compared to the expected duration of inclusion. sponsor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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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.
Patricia THOREUX, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meniscal Allograft in people with Meniscectomy Sequelae, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
The study was stopped early (reason given: Insufficient number of patients included compared to the expected duration of inclusion. sponsor's decision). Results are not available in the source record.
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?
"Function" Subscale in the Koos Scale (area under the curve) (time frame: 2 years follow up). 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 2 Sep 2020.