Osteoarthritis HandPhase 2NCT05250726
Use of a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) in the Treatment of Scaphotrapeziotrapezoid Osteoarthritis
A Phase 2 study testing MENISC-T in people with Osteoarthritis Hand, run by TBF Genie Tissulaire at 1 site in France.
Trial summary
The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- MENISC-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 8 Feb 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; age between 18 and 75 years.
- Patient with symptomatic STT OA.
- Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
- Patient with a QuickDash score > 33 points (converted to 50%).
- Patient with wrist pain (VAS) in front of the STT joint at rest > 4/10.
- Patient who received the study information and provided consent.
- Member or beneficiary of a national health insurance plan.
Who cannot join
- Pregnant or breastfeeding woman; woman without effective contraception.
- Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
- Patient with signs of neuropathy with functional disorders such as hyperesthesia.
- Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
- Person confined by a judicial or administrative decision.
- Adult subjected to legal protection measures or unable to provide his/her consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, 69100
About this study
Official title: Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis with a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT osteoarthritis.
- Conditions
- Osteoarthritis Hand
- Being tested
- MENISC-T
- Keywords
- ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENISC-TBiological
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint
| Study group | Role | What they receive |
|---|---|---|
| MENISC-T | Experimental | Segmented, devitalized and sterile meniscus graft Receives: Biological: MENISC-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of the symptomatology related to the STT OA
Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
Measured: 12 months
Secondary outcomes (4)
Absence of toxicity
Absence of adverse events
Measured: Through study completion - average of 12 months
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test
Measured: 1 month, 3 months, 6 months, 12 months
Decrease of pain related to STT OA
Pain evaluated from 0: no pain to 10: worst imaginable pain on visual analog scale (VAS)
Measured: 1 month, 3 months, 6 months, 12 months
No apparent anomaly of joint space
Joint space evaluated on radiography using Crosby's classification
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Jan 2021
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250726
- Sponsor's protocol ID
- MENISC-T-STT
- Other IDs
- 2020-A02916-33
- Status last verified
- Nov 2024
- First submitted
- 10 Feb 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis with a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
- ClinicalTrials.gov ID
- NCT05250726
- Acronym / sponsor ID
- MENISC-T-STT
- Conditions
- Osteoarthritis Hand
- Keywords
- ScaphoTrapezioTrapezoid OsteoArthritis (STT OA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 22 Feb 2022 (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 purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MENISC-T | Experimental | Biological: MENISC-TSegmented, devitalized and sterile meniscus graft |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female; age between 18 and 75 years.
- Patient with symptomatic STT OA.
- Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
- Patient with a QuickDash score > 33 points (converted to 50%).
- Patient with wrist pain (VAS) in front of the STT joint at rest > 4/10.
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman; woman without effective contraception.
- Patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically.
- Patient with signs of neuropathy with functional disorders such as hyperesthesia.
- Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
- Person confined by a judicial or administrative decision.
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 |
|---|---|---|
| MENISC-TDecellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of meniscus used as interposition at the STT joint | Biological | MENISC-T |
Primary outcome
Decrease of the symptomatology related to the STT OA
Time frame: 12 months
Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
4 secondary outcomes
Absence of toxicity
Time frame: Through study completion - average of 12 months
Increase of thumb strength
Time frame: 1 month, 3 months, 6 months, 12 months
Decrease of pain related to STT OA
Time frame: 1 month, 3 months, 6 months, 12 months
No apparent anomaly of joint space
Time frame: 12 months
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 14 Nov 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. This study is not recruiting at the moment.
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?
A Phase 2 study testing MENISC-T in people with Osteoarthritis Hand, run by TBF Genie Tissulaire at 1 site 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 7 inclusion and 6 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 14 Nov 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease of the symptomatology related to the STT OA (time frame: 12 months). 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 14 Nov 2024.