Repair of Meniscal InjuryREKREATENCT02732873
Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair
A study testing FibroFix Meniscal Scaffold in people with Repair of Meniscal Injury, run by Orthox Limited.
Trial summary
The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Repair of Meniscal Injury
- What is being tested?
- FibroFix Meniscal Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2017
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subject (or guardian, if appropriate) has signed and dated a specific informed consent form;
- The subject is over the age of 18 and ≤55 years of age;
- The subject is able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the Investigator;
- The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect;
- The meniscal defect should represent 25% or more of the meniscus and be amenable to implantation;
- The peripheral meniscal rim must be present;
Show all 10Show fewer
- The subject has a functionally intact ACL (Anterior Cruciate Ligament);
- Haemoglobin >9g/dL and platelet count >100,000/mm3 prior to Day 1;
- No contraindication to general anaesthetic;
- Female subjects of child-bearing potential: a negative urine pregnancy test.
Who cannot join
- Subject is >55 years of age;
- The subject has a functionally deficient ACL;
- The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation programme;
- The subject has a diagnosis of Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint;
- Patients demonstrating an active local or systemic infection;
- Any condition, which in the judgment of the Investigator would preclude adequate evaluation of the FibroFix™ Meniscus scaffold and clinical outcome;
Show all 12Show fewer
- The subject has a history of confirmed anaphylactoid reaction;
- The subject has received local administration of any type of corticosteroid or systemic administration of antineoplastic, immunostimulating, or immunosuppressive agents within 180 days prior to the scheduled surgery;
- The subject has evidence of osteonecrosis of the involved knee;
- The subject has a medical history that includes a confirmed diagnosis of rheumatoid or inflammatory arthritis, or relapsing polychondritis;
- If female and of child-bearing potential: evidence of a positive pregnancy test or a stated intention to become pregnant in the next 6-12 months;
- Current or recent (<3 months) participation in another device or drug study.
About this study
Official title: A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus
The REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.
- Conditions
- Repair of Meniscal Injury
- Being tested
- FibroFix Meniscal Scaffold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroFix Meniscal ScaffoldDevice
FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
| Study group | Role | What they receive |
|---|---|---|
| FibroFix | Experimental | Not described Receives: Device: FibroFix Meniscal Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance analysis of meniscal scaffold
Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner)
Measured: At 12 months follow up
Secondary outcomes (3)
Clinical criteria: quality of life
Subjective assessments using internationally validated questionnaires EQ5D
Measured: At 12 months follow up
Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications
Incidence and severity of Adverse Events; incidence and severity of surgical complications
Measured: At 12 months follow up
Clinical criteria: pain
At 12 months follow up
Measured: At 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Grant not received - study not started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repair of Meniscal InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthox Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southmead Hospital, Bristol, UK, Magdeburg University Hospital, Germany, University Hospital Brandenburg, BundeswehrKrankenhaus Ulm, Germany, Universitat Autonoma de Barcelona, Centre Hospitalier du Luxembourg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732873
- Sponsor's protocol ID
- ORX/2016/FM02
- Acronym
- REKREATE
- Status last verified
- Oct 2022
- First submitted
- 9 Mar 2016
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Study Evaluating the Treatment of Meniscal Defects With a Meniscal Repair Scaffold, FibroFix™ Meniscus
- ClinicalTrials.gov ID
- NCT02732873
- Acronym / sponsor ID
- REKREATE / ORX/2016/FM02
- Conditions
- Repair of Meniscal Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant not received - study not started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orthox LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Southmead Hospital, Bristol, UK, Magdeburg University Hospital, Germany, University Hospital Brandenburg, BundeswehrKrankenhaus Ulm, Germany, Universitat Autonoma de Barcelona, Centre Hospitalier du Luxembourg
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 11 Apr 2016 (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 REKREATE project will be an international, multi-centre, non-randomised, prospective single-arm pivotal study. All study patients will receive the FibroFix™ Meniscus scaffold following the provision of informed consent. A study period of 1 year and extended follow up period of up to 3 years is planned , to enable a thorough and complete assessment of the performance of the device when implanted to replace removed or damaged meniscal tissue in humans. The test article for this multi-centre study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FibroFix | Experimental | Device: FibroFix Meniscal Scaffold |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject (or guardian, if appropriate) has signed and dated a specific informed consent form;
- The subject is over the age of 18 and ≤55 years of age;
- The subject is able to comply with the protocol-defined pre-operative procedures, the post-operative clinical and radiographic evaluations and the recommended rehabilitation regimen as determined by the Investigator;
- The subject has a diagnosis of an MRI or arthroscopically confirmed irreparable medial meniscus defect;
- The meniscal defect should represent 25% or more of the meniscus and be amenable to implantation;
Key exclusion criteria (12 listed)
- Subject is >55 years of age;
- The subject has a functionally deficient ACL;
- The subject has concomitant posterior cruciate ligament insufficiency of the involved knee or a concomitant injury that interferes with the subject's ability to comply with the recommended rehabilitation programme;
- The subject has a diagnosis of Grade IV Outerbridge Scale degenerative cartilage disease in the involved knee joint;
- Patients demonstrating an active local or systemic 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 |
|---|---|---|
| FibroFix Meniscal ScaffoldFibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear. | Device | FibroFix |
Primary outcome
Performance analysis of meniscal scaffold
Time frame: At 12 months follow up
Performance will be assessed by means of recognised, validated, standardised questionnaires (IKDC, Lysholm, Tegner)
3 secondary outcomes
Clinical criteria: quality of life
Time frame: At 12 months follow up
Assessment of safety of meniscal scaffold - Incidence and severity of Adverse Events; incidence and severity of surgical complications
Time frame: At 12 months follow up
Clinical criteria: pain
Time frame: At 12 months follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
Related trials for Repair of Meniscal Injury
RecruitingObservational study
Surgical Outcome After Displaced Bucket-handle Meniscal Lesions - Repair Versus Partial Meniscectomy
Meniscus Rupture, Meniscus Injury
Active, not recruiting
Comparison of Isolated Meniscus Repair Versus Combined Meniscus Repair and Notch Microfracture: A Randomized Controlled Trial Evaluating Functional and Imaging Outcomes
Meniscus Injury
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.
Questions about this trial
What is this clinical trial studying?
A study testing FibroFix Meniscal Scaffold in people with Repair of Meniscal Injury, run by Orthox Limited.
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 10 inclusion and 12 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: withdrawn, as of the sponsor's last update on 12 Oct 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Performance analysis of meniscal scaffold (time frame: At 12 months 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 12 Oct 2022.