PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

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 CE-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, multicentre, 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.

A total of 55 subjects will be enrolled into the study. 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.

Study Overview

• Status: Recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Device: AchilloCordPLUS™ System Implant

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Charlotte Butterworth-Pool; Phone Number: 01172180030; Email: Charlotte.Butterworth-Pool@xiros.co.uk
• Study Contact Backup: Name: Vikki Adams; Email: vikki.adams@xiros.co.uk

Study Locations

• United Kingdom
  • Penrith, United Kingdom, CA11 7BF
    • Recruiting
    • North Cumbria Integrated Care NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring end to end repair for acute Achilles tendon rupture.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AchilloCordPLUS; End to end repair for acute Achilles tendon rupture with AchilloCordPLUS	Device: AchilloCordPLUS™ System Implant; AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles Tendon Rupture Score (ATRS)	Change in ATRS Score 0-100 0=major limitations 100=no limitations	6 months
adverse events (AE)	Number of adverse events (AE) at 6 months after surgery which directly relate to the procedure that may have an effect on the patient's outcome (for example, irritation at the surgery site, re-rupture, deep-vein thrombosis (DVT), wound infection and sural nerve damage).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achilles Tendon Rupture Score (ATRS)	Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations	2 years
Length of time to unaided full weight bearing	Length of time to defined as removal of heel raise and walking unaided	2 years
return to work and return to sport.	Time for patients to return to work and return to sport.	2 years
Tegner Activity Scale	Number of patients who have returned to pre-injury levels of activity assessed using the Tegner Activity Scale 10 (competitive sport) 0 (sick leave or disability pension)	2 years
RAND Short Form 36 (SF 36) V1	Change from RAND SF 36 Patient-reported quality of life 0-100 a higher sore indicates a higher health state	2 years
Tegner Activity Scale	Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension)	2 years
Range of Motion	Change in ROM (ankle dorsi and plantar flexion) between each time point up to 6 months after surgery and compare to the contralateral side.	6 months
Calf Circumference	Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side.	6 months
Adverse Event	Adverse events up to 2 years after surgery which directly relate to the procedure that may have an effect on the patient's outcome (for example, irritation at the surgery site, rerupture, DVT, wound infection and sural nerve damage).	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Isokinetic muscle strength of both ankles measured by a dynamometer.	Change in strength (isokinetic) from 6 weeks up to 6 months and compare to the contralateral side (optional, only if the site has the equipment to conduct this)	6 months

Collaborators and Investigators

• Sponsor: Xiros Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: CRE 029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No