Long-term Follow-up of Actifit® Meniscal Scaffold Patients.

NCT07800923 | Not Yet Recruiting DMC

• 1 other identifier: Actifit CIP30014
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4-6 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with an Actifit scaffold more than 4 years ago with the implant still intact and a baseline IKDC score.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Orteq Sports Medicine: lead

Study Sites (1)

University Hospital Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Links

• Link to study sponsor where the product that was used in the study patients (at a minimum of 4 years ago) is explained.

Study Officials

• Clayton Wilson

  Orteq Sports Medicine

  STUDY CHAIR

Central Study Contacts

Lieven Huysse, MD

CONTACT

+32 477 96 06 23; lhuysse@orteq.com

Sharon H Griffin, CIM

CONTACT

9412170304; sgriffin@orteq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: September 2, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

BE (1)