Meniscus LesionNCT07800923
Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
An observational study of Meniscus Lesion and Meniscus Tear, run by Orteq Sports Medicine at 1 site in Belgium.
Trial summary
This study will collect retrospective patient data of Actifit patients (medial and lateral, isolated cases as well as cases with concomitant procedures), including pre-op and any post-op imaging, for 120 retrospective Actifit patients, to account for drop-outs and patients refusing a follow-up visit/follow-up imaging. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Meniscus Lesion, Meniscus Tear
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients implanted with an Actifit scaffold more than 4 years ago with the implant still intact and a baseline IKDC score.
Who may be able to join
- At time of operation, with respect to the involved knee:
- Patients with irreparable, painful and/or dysfunctional meniscal tissue loss having undergone partial meniscectomy.
- Sufficient rim over the entire circumference of the meniscus to ensure stable fixation.
- Well aligned knee joint (varus/valgus <5o) or willing to correct alignment at implant surgery
- Stable knee joint or ACL deficiencies corrected within 12 weeks after implantation of Actifit.
- ICRS classification ≤ 3.
Show all 10Show fewer
- No more than 3 prior meniscal surgeries on the involved knee.
- Skeletally mature men or women, aged 16 to 50 years at time of Actifit procedure.
- Actifit implantation at a minimum of 4 years ago
- Willing to participate in this long-term follow-up study.
Who cannot join
- At time of operation:
- PCL insufficiency of the involved knee.
- Significant uncorrected malformations, axial malalignment in the ipsilateral leg.
- Documented allergy to any of the product components.
- Systemic or local infection at the time of the operation.
- Overweight at the time of operation (defined as BMI greater than 35kg/m²)
Show all 10Show fewer
- Systemic administration of any type of corticosteroid, antineoplastics, immune-stimulating or immunosuppressive agent within 30 days before or after implantation of Actifit.
- Evidence of osteonecrosis in the involved knee at the time of the operation.
- Medical history at time of operation that is positive, for, but not restricted to, the following diseases:
- Rheumatoid arthritis Relapsing polychondritis Severe degenerative osteoarthrosis Inflammatory arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
University Hospital Gent
Ghent, Oost-Vlaanderen, 9000
Nele Arnout, MD, +329332 22 51, bws@uzgent.be
About this study
This study will collect retrospective patient data of Actifit patients (medial and lateral, isolated cases as well as cases with concomitant procedures), including pre-op and any post-op imaging, for 120 retrospective Actifit patients, to account for drop-outs and patients refusing a follow-up visit/follow-up imaging.
Each patient without evidence of previous removal of the scaffold, revision to arthroplasty or joint-modifying surgery at the index knee will be contacted by the site, first by phone, to check whether the Actifit device is still in place or not. If no longer in place, patient's situation will be clearly documented, this will preferentially be done via phone or, if necessary, via a prospective visit. If the Actifit is still in place, a prospective follow-up visit will be organised so that patient's current situation can be documented. The prospective follow-up visit may be via an in-person clinic visit (preferred since the visit, provided the patients agrees, includes imaging), telephone or video conference. Any newly occurring events during this prospective visit will also be documented. Of the 120 retrospective patients, we anticipate a group of about 60-100 study participants with the Actifit still in place and being invited to a prospective follow-up visit.
Consent will be requested to collect specific questionnaires (IKDC, KOOS, VAS-pain and, in case available at baseline, Lysholm) and, in case the study participant also agrees to this, an X-Ray/MRI will be collected, provided any previous imaging is > 365 days old.
Read the detailed description
This multicentre study is intended to document the mid- and long-term clinical safety and effectiveness in patients treated with the Actifit meniscus scaffold.
The purpose of this study is to document the mid- and long-term safety and effectiveness of the Actifit Meniscal Scaffold and allow comparisons with other treatment modalities.
Primary Objective:
The primary objective of this study is to collect data to document the safety and effectiveness (IKDC) of the Actifit Meniscal Scaffold at 4-6 years in study participants with an Actifit procedure for the medial or lateral meniscus (isolated or in combination with one or more additional procedures).
Secondary Objectives: The secondary objectives of this study are: 1. To collect safety and effectiveness (IKDC) data on the Actifit Meniscal Scaffold in medial, lateral, isolated or combined procedures at 7-12 years and 12+ years and compare to baseline.2. To collect safety and effectiveness (IKDC) data on the Actifit Meniscal Scaffold in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus at 4-6 years, 7-12 years and 12+ years and compare to baseline.
Additional objectives: 1. To compare VAS, KOOS and, if available, Lysholm preop - to mid- and long-term postoperative outcomes for patients treated with the Actifit® scaffold. 2. To compare preop- (if available) to mid- and long-term postoperative radiographs (baseline to 4-6 years and to the last available radiographs) for patients treated with the Actifit® scaffold. 3. To assess the knee on MRI at mid- and long-term follow-up intervals, if available, and, compare to baseline MRI. 4. To assess (serious) events related to the Actifit device and/or procedure through each of the time points: 4-6 years (this includes any clinically relevant event since the Actifit® operation), 7-12 years and 12+ years.
Two co-primary endpoints in Actifit® procedures at the medial or lateral meniscus (isolated or combined) at 4-6 years of follow-up: 1. Efficacy: the percent improvement in the IKDC from baseline to the 4-6 years follow-up point. 2. Safety/survival: the percentage of study participants at 4-6 years of follow-up, with the device (Actifit®) still in place (not removed); and who did not require conversion to arthroplasty or other joint-modifying surgery (e.g. osteotomy) (Kaplan-Meier survival curves).
Descriptive statistics will be presented for the secondary and additional endpoints below.
Secondary endpoints: Efficacy: Long-term efficacy: IKDC improvement from baseline to 7 - 12 years and 12+ years follow-up in Actifit® procedures (medial or lateral, isolated or combined). Mid- and long-term efficacy: IKDC improvement from baseline to 4-6 years, 7 - 12 years and 12+ years follow-up in Actifit Meniscal Scaffold procedures in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus Safety: Long-term safety/survival (device in place, no joint-modifying surgery) at 7 - 12 years and 12+ years follow-up) in Actifit procedures (medial or lateral, isolated or combined) (Kaplan-Meier survival curves). Mid- and long-term safety/survival (device in place, no joint-modifying surgery) at 4-6 years, 7 - 12 years and 12+ years follow-up of Actifit Meniscal Scaffold procedures in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus, (Kaplan-Meier survival curves).
Additional Endpoints:
Efficacy: Compare preop- to mid- and long-term (4-6, 7-12 years and 12+ years) postoperative outcomes (VAS, KOOS, and, if available, Lysholm) for patients treated with the Actifit scaffold. Compare preop- to mid- and long-term postoperative radiographs for patients treated with the Actifit scaffold (joint space height, Kellgren-Lawrence score, …) at 4-6 years and the last available radiographs (that are > 365 days passed the 4-6 year images). Assess the knee on MRI at long-term follow-up visits: 4-6 and the last available MRI (that is > 365 days passed the 4-6 year MRI), including the WORMS score and other relevant assessments to baseline MRI (contrast or no contrast, before or ≤ 6 months post Actifit procedure) when available. If baseline MRI is not available: assess knee and meniscal condition at long-term follow-up time points.
Safety: Procedure related (serious) events and (serious) device related incidents, side-effects through each of the time points: 4-6 years and since the Actifit operation, 7-12 years and 12+ years.
All endpoints will be analysed separately for adherence to instructions for use, isolated medial or lateral procedures, pooled (isolated and combined) medial or lateral procedures, as well as pooled analyses for the overall cohort (medial, lateral, isolated, combined). Except for the analyses of the overall cohort, the analyses will be exploratory only and will not be used to make claims.
- Conditions
- Meniscus Lesion, Meniscus Tear
- Keywords
- Meniscal scaffold for use in the treatment of irrepairable meniscus tears and meniscal tissue loss., Meniscal scaffold, Meniscal tear, Meniscal lesion, Actifit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have been treated with an Actifit meniscal scaffold | For patients implanted with an Actifit device 4 - 12+ years ago and still have the device in place, consent will be requested to collect specific questionnaires (IKDC, KOOS, VAS-pain) and, in case the study participant also agrees to this, an X-Ray/MRI will be collected, provided any previous imaging is > 365 days old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the Actifit Meniscal Scaffold
The primary objective of this study is to collect data to document the effectiveness (IKDC) of the Actifit Meniscal Scaffold at 4-6 years in study participants with an isolated Actifit procedure for the medial meniscus Description: Effectiveness: For the IKDC. 0 is the worst score and indicates extreme pain and functional limitation. 100 is the best score and indicates no pain and no functional limitation.
Measured: 4-6 years
Safety of the Actifit Meniscal Scaffold
Safety/survival: the percentage of study participants at 4-6 years of follow-up, with the device (Actifit) still in place (not removed); and who did not require conversion to arthroplasty or other joint-modifying surgery (e.g. osteotomy) (Kaplan-Meier survival curves) will be calculated.
Measured: 4-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orteq Sports Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clayton Wilson, Study chair, Orteq Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800923
- Sponsor's protocol ID
- Actifit CIP30014
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of Actifit® Meniscal Scaffold Patients.
- ClinicalTrials.gov ID
- NCT07800923
- Acronym / sponsor ID
- Actifit CIP30014
- Conditions
- Meniscus Lesion, Meniscus Tear
- Keywords
- Meniscal scaffold for use in the treatment of irrepairable meniscus tears and meniscal tissue loss., Meniscal scaffold, Meniscal tear, Meniscal lesion, Actifit
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Orteq Sports MedicineIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 2 Sep 2026 (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.
This study will collect retrospective patient data of Actifit patients (medial and lateral, isolated cases as well as cases with concomitant procedures), including pre-op and any post-op imaging, for 120 retrospective Actifit patients, to account for drop-outs and patients refusing a follow-up visit/follow-up imaging.
Each patient without evidence of previous removal of the scaffold, revision to arthroplasty or joint-modifying surgery at the index knee will be contacted by the site, first by phone, to check whether the Actifit device is still in place or not. If no longer in place, patient's situation will be clearly documented, this will preferentially be done via phone or, if necessary, via a prospective visit. If the Actifit is still in place, a prospective follow-up visit will be organised so that patient's current situation can be documented. The prospective follow-up visit may be via an in-person clinic visit (preferred since the visit, provided the patients agrees, includes imaging), telephone or video conference. Any newly occurring events during this prospective visit will also be documented. Of the 120 retrospective patients, we anticipate a group of about 60-100 study participants with the Actifit still in place and being invited to a prospective follow-up visit.
Consent will be requested to collect specific questionnaires (IKDC, KOOS, VAS-pain and, in case available at baseline, Lysholm) and, in case the study participant also agrees to this, an X-Ray/MRI will be collected, provided any previous imaging is > 365 days old.
Detailed description
This multicentre study is intended to document the mid- and long-term clinical safety and effectiveness in patients treated with the Actifit meniscus scaffold.
The purpose of this study is to document the mid- and long-term safety and effectiveness of the Actifit Meniscal Scaffold and allow comparisons with other treatment modalities.
Primary Objective:
The primary objective of this study is to collect data to document the safety and effectiveness (IKDC) of the Actifit Meniscal Scaffold at 4-6 years in study participants with an Actifit procedure for the medial or lateral meniscus (isolated or in combination with one or more additional procedures).
Secondary Objectives: The secondary objectives of this study are: 1. To collect safety and effectiveness (IKDC) data on the Actifit Meniscal Scaffold in medial, lateral, isolated or combined procedures at 7-12 years and 12+ years and compare to baseline.2. To collect safety and effectiveness (IKDC) data on the Actifit Meniscal Scaffold in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus at 4-6 years, 7-12 years and 12+ years and compare to baseline.
Additional objectives: 1. To compare VAS, KOOS and, if available, Lysholm preop - to mid- and long-term postoperative outcomes for patients treated with the Actifit® scaffold. 2. To compare preop- (if available) to mid- and long-term postoperative radiographs (baseline to 4-6 years and to the last available radiographs) for patients treated with the Actifit® scaffold. 3. To assess the knee on MRI at mid- and long-term follow-up intervals, if available, and, compare to baseline MRI. 4. To assess (serious) events related to the Actifit device and/or procedure through each of the time points: 4-6 years (this includes any clinically relevant event since the Actifit® operation), 7-12 years and 12+ years.
Two co-primary endpoints in Actifit® procedures at the medial or lateral meniscus (isolated or combined) at 4-6 years of follow-up: 1. Efficacy: the percent improvement in the IKDC from baseline to the 4-6 years follow-up point. 2. Safety/survival: the percentage of study participants at 4-6 years of follow-up, with the device (Actifit®) still in place (not removed); and who did not require conversion to arthroplasty or other joint-modifying surgery (e.g. osteotomy) (Kaplan-Meier survival curves).
Descriptive statistics will be presented for the secondary and additional endpoints below.
Secondary endpoints: Efficacy: Long-term efficacy: IKDC improvement from baseline to 7 - 12 years and 12+ years follow-up in Actifit® procedures (medial or lateral, isolated or combined). Mid- and long-term efficacy: IKDC improvement from baseline to 4-6 years, 7 - 12 years and 12+ years follow-up in Actifit Meniscal Scaffold procedures in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus Safety: Long-term safety/survival (device in place, no joint-modifying surgery) at 7 - 12 years and 12+ years follow-up) in Actifit procedures (medial or lateral, isolated or combined) (Kaplan-Meier survival curves). Mid- and long-term safety/survival (device in place, no joint-modifying surgery) at 4-6 years, 7 - 12 years and 12+ years follow-up of Actifit Meniscal Scaffold procedures in isolated procedures of the medial or lateral meniscus, as well as in pooled isolated and combined procedures at the medial or lateral meniscus, (Kaplan-Meier survival curves).
Additional Endpoints:
Efficacy: Compare preop- to mid- and long-term (4-6, 7-12 years and 12+ years) postoperative outcomes (VAS, KOOS, and, if available, Lysholm) for patients treated with the Actifit scaffold. Compare preop- to mid- and long-term postoperative radiographs for patients treated with the Actifit scaffold (joint space height, Kellgren-Lawrence score, …) at 4-6 years and the last available radiographs (that are > 365 days passed the 4-6 year images). Assess the knee on MRI at long-term follow-up visits: 4-6 and the last available MRI (that is > 365 days passed the 4-6 year MRI), including the WORMS score and other relevant assessments to baseline MRI (contrast or no contrast, before or ≤ 6 months post Actifit procedure) when available. If baseline MRI is not available: assess knee and meniscal condition at long-term follow-up time points.
Safety: Procedure related (serious) events and (serious) device related incidents, side-effects through each of the time points: 4-6 years and since the Actifit operation, 7-12 years and 12+ years.
All endpoints will be analysed separately for adherence to instructions for use, isolated medial or lateral procedures, pooled (isolated and combined) medial or lateral procedures, as well as pooled analyses for the overall cohort (medial, lateral, isolated, combined). Except for the analyses of the overall cohort, the analyses will be exploratory only and will not be used to make claims.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have been treated with an Actifit meniscal scaffold | – | –For patients implanted with an Actifit device 4 - 12+ years ago and still have the device in place, consent will be requested to collect specific questionnaires (IKDC, KOOS, VAS-pain) and, in case the study participant also agrees to this, an X-Ray/MRI will be collected, provided any previous imaging is > 365 days old. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients implanted with an Actifit scaffold more than 4 years ago with the implant still intact and a baseline IKDC score.
Key inclusion criteria (10 listed)
- Patients with irreparable, painful and/or dysfunctional meniscal tissue loss having undergone partial meniscectomy.
- Sufficient rim over the entire circumference of the meniscus to ensure stable fixation.
- Well aligned knee joint (varus/valgus <5o) or willing to correct alignment at implant surgery
- Stable knee joint or ACL deficiencies corrected within 12 weeks after implantation of Actifit.
- ICRS classification ≤ 3.
Key exclusion criteria (10 listed)
- PCL insufficiency of the involved knee.
- Significant uncorrected malformations, axial malalignment in the ipsilateral leg.
- Documented allergy to any of the product components.
- Systemic or local infection at the time of the operation.
- Overweight at the time of operation (defined as BMI greater than 35kg/m²)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of the Actifit Meniscal Scaffold
Time frame: 4-6 years
The primary objective of this study is to collect data to document the effectiveness (IKDC) of the Actifit Meniscal Scaffold at 4-6 years in study participants with an isolated Actifit procedure for the medial meniscus Description: Effectiveness: For the IKDC. 0 is the worst score and indicates extreme pain and functional limitation. 100 is the best score and indicates no pain and no functional limitation.
Safety of the Actifit Meniscal Scaffold
Time frame: 4-6 years
Safety/survival: the percentage of study participants at 4-6 years of follow-up, with the device (Actifit) still in place (not removed); and who did not require conversion to arthroplasty or other joint-modifying surgery (e.g. osteotomy) (Kaplan-Meier survival curves) will be calculated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Link to study sponsor where the product that was used in the study patients (at a minimum of 4 years ago) is explained.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Clayton Wilson study chair
Orteq Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Lesion and Meniscus Tear, run by Orteq Sports Medicine at 1 site in Belgium.
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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lieven Huysse, MD (+32 477 96 06 23, lhuysse@orteq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of the Actifit Meniscal Scaffold (time frame: 4-6 years). The study lists 2 primary outcomes in all. 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 2026.