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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorOrteq Sports Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: Patients who have been treated with an Actifit meniscal scaffold

Trial outcomes

Primary outcomes

1

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.

Time frame
4-6 years
2

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.

Time frame
4-6 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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