Other Tear of Medial Meniscus, Current InjuryNCT02205645
Initial Safety Evaluation of FibroFix™ Meniscus
A study testing FibroFix™ Meniscus scaffold in people with Other Tear of Medial Meniscus, Current Injury, run by Orthox Limited at 1 site in United Kingdom.
Trial summary
Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other Tear of Medial Meniscus, Current Injury
- What is being tested?
- FibroFix™ Meniscus scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to 17 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
- The subject is able to comply with the protocol-defined preoperative procedures, the postoperative 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 repair
- The peripheral meniscal rim must be present
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- The subject has a functionally intact 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
- The subject has a functionally deficient anterior cruciate ligament
- 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 program
- The subject has a diagnosis of untreatable 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.
- The subject has a history of confirmed anaphylactoid reaction
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects
Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold
Read the detailed description
The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal defect
- Being tested
- FibroFix™ Meniscus scaffold
- Keywords
- medial, meniscus, scaffold, repair, tear, injury
- Medical subject headings
- Lacerations, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroFix™ Meniscus scaffoldDevice
The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus.
The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
| Study group | Role | What they receive |
|---|---|---|
| FibroFix™ Meniscus scaffold | Experimental | The test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear. Receives: Device: FibroFix™ Meniscus scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Number of participants with Adverse Events
Measured: 12 months
Secondary outcomes (2)
Safety
Number of participants with Adverse Events
Measured: 7 years
Functional assessment
Assessments will be made using recognized and validated tools: Tegner Index, Lysholm Score, International Knee Documentation Committee (IKDC) Score and range of motion of knee
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startApr 2015
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Why it stopped: Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Tear of Medial Meniscus, Current 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthox Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK, University of Bristol
- Responsible party
- Sponsor
- Investigators
- Ashley Blom, Professor, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205645
- Sponsor's protocol ID
- ORX/2014/FM01
- Status last verified
- Apr 2017
- First submitted
- 23 Jul 2014
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-Label Study to Evaluate the Safety of the Meniscal Repair Scaffold, FibroFix™ Meniscus, in the Treatment of Meniscal Defects
- ClinicalTrials.gov ID
- NCT02205645
- Acronym / sponsor ID
- ORX/2014/FM01
- Keywords
- medial, meniscus, scaffold, repair, tear, injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Orthox LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Avon Orthopaedic Centre, North Bristol NHS Trust, Bristol UK, University of Bristol
- Study start
- Apr 2015
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 31 Jul 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.
Initial evaluation of safety and performance of FibroFix™ Meniscus scaffold
Detailed description
The safety of the FibroFix™ Meniscus scaffold will be evaluated in 10 patients scheduled for elective arthroscopic medial meniscus partial resection or treatment of asymptomatic medial meniscal defect
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FibroFix™ Meniscus scaffold | Experimental | Device: FibroFix™ Meniscus scaffoldThe test article for this study is the FibroFix™ Meniscus scaffold, which has been developed for repair of defects of the meniscus. It is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
- The subject is able to comply with the protocol-defined preoperative procedures, the postoperative 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 repair
Key exclusion criteria (10 listed)
- The subject has a functionally deficient anterior cruciate ligament
- 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 program
- The subject has a diagnosis of untreatable 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.
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™ Meniscus scaffoldThe test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus. The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear. | Device | FibroFix™ Meniscus scaffold |
Primary outcome
Safety
Time frame: 12 months
Number of participants with Adverse Events
2 secondary outcomes
Safety
Time frame: 7 years
Functional assessment
Time frame: 7 years
Results and safety
The study was stopped early (reason given: Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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.
Ashley Blom, Professor principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibroFix™ Meniscus scaffold in people with Other Tear of Medial Meniscus, Current Injury, run by Orthox Limited at 1 site in United Kingdom.
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 10 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 13 Mar 2019. 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 Kingdom. 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: Safety. Devices explanted. 12m post-explant safety f/u as agreed with UK MHRA). 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?
Safety (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 13 Mar 2019.