Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction

Xiros Ltd59 enrolled

Overview

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 Devices in this study, 10mm Poly-Tape and 5mm Infinity-Lock Tape, are Class III CE-Marked devices manufactured by Xiros Ltd. Both devices fall under the Poly-Tape family. Poly-Tapes are single-use devices, they are indicated for patients requiring soft tissue approximation and reconstruction of ligaments and tendons. 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 either the 10mm Poly-Tape or 5mm Infinity-Lock Tape for MPFL reconstruction, will be consecutively recruited into the study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Medial Patellofemoral Dislocation

Interventions

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

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.

Locations (5)

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, United Kingdom

RECRUITING

Tameside and Glossop Integrated Care NHS Foundation Trust

Manchester, United Kingdom

RECRUITING

University of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Winchester, United Kingdom

RECRUITING

Somerset NHS Foundation Trust

Yeovil, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Kujala Score

The primary performance objective is to determine the effect of MPFL reconstruction on symptoms and functional limitations 1 year after surgery, measured using the Kujala .Total score. Total scores range from 0 to 100 with high scores indicating good

Time frame: 1 year

Redislocation/subluxation events

The primary safety objective is to assess redislocation/subluxation events at 1 year after surgery

Time frame: 1 year

Secondary Outcomes

Full range of motion (ROM)

Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Full range of motion (ROM)

Time frame: 5 years

Norwich Patellar Instability (NPI) score

Change from baseline Norwich Patellar Instability (NPI) score at each visit up to 1 year. The score is made up of 0 to 250. Out of the total score-able answers, where "don't do" answered questions are deducted, the total score is then converted as a percentage based on the number of scored responses provided. A higher percentage indicate higher severity of patellar instability

Time frame: 5 years

Patient-reported quality of life (RANDShort form 36)

Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient-reported quality of life 0-100 a higher sore indicates a higher health state

Time frame: 5 years

Patient-reported activity levels

Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient-reported activity levels 0-10 , 10 is a high level of activity

Time frame: 5 years

Patient satisfaction with Surgery

Secondary performance objectives are to determine the effect of MPFL reconstruction on the following during the performance lifetime of the device: Patient satisfaction with Surgery. Yes or No

Time frame: 5 years

Adverse events, including re-dislocation/subluxation

Secondary safety objectives include: Adverse events, including

Time frame: 5 years

Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts