Clinical trial NCT06166784: Interference Screw Mectascrew-B Postmarket Study
Official title: Cinical Outcomes of Mectascrew B Interference Screw
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Injuries Posterior Cruciate Ligament Tear
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2023-12-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with an ACL or PCL rupture, and meeting the inclusion/ exclusion criteria

Brief summary: An observational prospective study with the aim to assess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) in the reconstructive treatment of ruptured ACL or PCL by means of an autograft or allograft.

Detailed description: This is an observational prospective study with the aim toassess the clinical outcomes at 1year after surgery for a specific composite IS (Medacta Mectascrew B) at 12 months following ACL or PCL reconstruction.

Patients with an ACL or PCL tear scheduled for surgery at OCM Klnik GmbH hospital will be enrolled in the study, after the subscription of informed consent.

The injured ligament will be restored with an auto- or allograft that will be fixed with a composite IS (Mectascrew-B, Medacta International SA). Data concerning demography, preoperative clinical conditions, surgical details including device implanted, tendon harvesting procedure and complications occurred, postoperative clinical data (as per standard practice at 6 weeks, 6 and/or 12 months) will be prospectively collected, in order to assess the functional outcomes (IKDC objective and subjective) and the knee stability (ROM, Pivot Shift or Reverse Pivot Shift test, anterior or posterior drawer test) of the patients.

The treated knee will be also evaluated radiologically by std x-ray according to standard practice to assess swelling, tunnel widening, and resorption problems. The results of this exam will be correlated to the pre-operative findings and to the functional and clinical outcomes evaluated with the different forms

Eligibility criteria: Inclusion Criteria:

* Both genders
* Patients older than 18 years
* ACL or PCL damage requiring primary ACL or PCL reconstruction
* Patient requiring ACL or PCL surgery with the use of Medacta MectaScrew B interference screw, according to Manufacturer IFU's, i.e. reconstructive therapy of ruptures to the anterior or posterior cruciate ligament by means of autologous grafts
* Patients who are willing to participate in the study and have signed informed consent form.

Exclusion Criteria:

* Patients with contraindications according to IFU's
* Patients with malignant diseases (at the time of surgery)
* Patients with proven or suspected infections (at the time of surgery)
* Patients with functional deficits on the affected extremity (at the time of surgery)
* Patients with known incompatibility or allergy to products materials (at the time of surgery)
* Concomitant ligament injury (grade ≥ 3)

Primary outcomes:
measure: Functional outcomes evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Mobility outcomes evaluation
timeFrame: 6 weeks, 6 months, 12 months
measure: Knee stability evaluation of ACL intervention
timeFrame: 6 weeks, 6 months, 12 months
measure: ACL integrity assessment
timeFrame: 6 weeks, 6 months, 12 months
measure: Knee stability evaluation of PCL intervention
timeFrame: 6 weeks, 6 months, 12 months
measure: PCL integrity assessment
timeFrame: 6 weeks, 6 months, 12 months
measure: Interference screw integration
timeFrame: 6 weeks, 6 months, 12 months
measure: Incidence of adverse event
timeFrame: 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: Münich
country: Germany
facility: OCM Klinik GmbH
Study officials:
References: