Clinical trial NCT05304819: PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
Official title: Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Achilles Tendon Rupture
Lead sponsor: Xiros Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 19
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 requiring end to end repair for acute Achilles tendon rupture.

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 acute repair of the Achilles tendon.

The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.

Detailed description: 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 acute repair of the Achilles tendon.

The Medical Device in this study AchilloCordPLUS is a Class IIb UKCA-Marked device manufactured by Xiros Ltd.

AchilloCordPLUS is a single-use device, indicated for patients with acute Achilles tendon ruptures. It is particularly suited to active patients where an extended period of postoperative immobilisation is undesirable.

This study is a prospective, single-centre, consecutively recruited non-randomised study. The total length of the study is expected to be 3 years. This includes a recruitment period of approximately 12 months and a 2-year follow-up.

This study has now closed to follow-up, with a recruitment of 19 participants. Follow up is at 2,4,6,8 and 12 weeks, 6 months and 1 and 2 years. All subjects treated with the AchilloCordPLUS for acute Achilles tendon repair will be consecutively recruited into the study.

Eligibility criteria: Inclusion Criteria:

* Patients must be skeletally mature and be 18 years old or above.
* Patients requiring end to end repair for acute Achilles tendon rupture.
* Patient is willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and has provided written informed consent as approved by the Research Ethics Committee (REC).

Exclusion Criteria:

* Patients with chronic ruptures of the Achilles tendon.
* Patients with bilateral ruptures.
* Patients with known hypersensitivity to implant materials. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation.
* Patients with infections or any structural or pathological condition of the bone or soft tissue that would be expected to impair healing or prevent secure fixation.
* Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period.

Primary outcomes:
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 6 months
measure: adverse events (AE)
timeFrame: 6 months
Secondary outcomes:
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 2 years
measure: Length of time to unaided full weight bearing
timeFrame: 2 years
measure: return to work and return to sport.
timeFrame: 2 years
measure: Tegner Activity Scale (pre-injury)
timeFrame: 2 years
measure: RAND Short Form 36 (SF 36) V1
timeFrame: 2 years
measure: Tegner Activity Scale (baseline)
timeFrame: 2 years
measure: Range of Motion
timeFrame: 6 months
measure: Calf Circumference
timeFrame: 6 months
measure: Adverse Event
timeFrame: 2 years
Other outcomes:
Locations:
city: Penrith
country: United Kingdom
facility: North Cumbria Integrated Care Nhs Foundation Trust
Study officials:
References: