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NCT Number: NCT05264389

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

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 59 subjects will be enrolled into the study with follow up at 6 weeks, 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Medial Patellofemoral Dislocation

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

James Paget University Hospitals NHS Foundation Trust, Great Yarmouth, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Poly-Tape Devices

Device

Poly-Tape Devices, 10mm Poly-Tape or 5mm Infinity-Lock Tape, for Medial Patellofemoral Ligament (MPFL) Reconstruction

Other names: 10mm Poly-Tape, 5mm Infinity-Lock Tape

Primary outcomes

  1. Kujala Score

    Time frame: 1 year

    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

  2. Redislocation/subluxation events

    Time frame: 1 year

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

Secondary outcomes

  1. Full range of motion (ROM)

    Time frame: 5 years

    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)

  2. Norwich Patellar Instability (NPI) score

    Time frame: 5 years

    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

  3. Patient-reported quality of life (RANDShort form 36)

    Time frame: 5 years

    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

  4. Patient-reported activity levels

    Time frame: 5 years

    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

  5. Patient satisfaction with Surgery

    Time frame: 5 years

    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

  6. Adverse events, including re-dislocation/subluxation

    Time frame: 5 years

    Secondary safety objectives include: Adverse events, including

Sponsors and collaborators

Lead sponsor

Xiros Ltd

Industry

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2031
First posted
Mar 3, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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