Clinical trial NCT05264389: Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction
Official title: Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Device for Medial Patellofemoral Ligament (MPFL) Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Medial Patellofemoral Dislocation
Lead sponsor: Xiros Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 55
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require MPFL reconstruction.

Brief summary: This is a Post Market Clinical Follow Up Study in Orthopaedics. It will verify the long-term safety and performance of the device in the intended patient population, when indicated for the reconstruction of a ligament in the kneecap - the Medial Patellofemoral ligament (MPFL).

The Medical Device in this study, Poly-Tape, is a Class IIb CE-Marked device manufactured by Xiros Ltd. Poly-tapes are a single-use device, they are indicated for patients repair of soft tissue and/or reconstruction of ligaments, tendons, and other soft tissues. The device can be fixed to the bone using several different methods including screws.

This study is a prospective, multicentre, consecutively recruited non-randomised study. The total length of the study is expected to be 7 years. This includes a recruitment period of approximately 24 months and a 5-year follow-up. A total of 55 subjects will be enrolled into the study with follow up at 6 months, 1 year, 2 years and 5 years in clinic and by questionnaires. All subjects treated with the Poly-Tape for MPFL reconstruction, will be consecutively recruited into the study.


Eligibility criteria: Inclusion Criteria:

Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC).

Exclusion Criteria:

These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows.

Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.

Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery.

Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.

Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.

Primary outcomes:
measure: Kujala Score
timeFrame: 1 year
measure: Redislocation/subluxation events
timeFrame: 1 year
Secondary outcomes:
measure: Full range of motion (ROM)
timeFrame: 5 years
measure: Norwich Patellar Instability (NPI) score
timeFrame: 5 years
measure: Patient-reported quality of life (RANDShort form 36)
timeFrame: 5 years
measure: Patient-reported activity levels
timeFrame: 5 years
measure: Patient satisfaction with Surgery
timeFrame: 5 years
measure: Adverse events, including re-dislocation/subluxation
timeFrame: 5 years
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University of North Midlands NHS Trust
city: Winchester
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: Yeovil
country: United Kingdom
facility: Somerset NHS Foundation Trust
Study officials:
References: