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

Achilles Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05304819
• Other study ID #: CRE 029
• Status: Recruiting
• Start date: March 9, 2022
• Est. completion date: September 2026

Study information

• Verified date: October 2023
• Source: Xiros Ltd
• Contact: Charlotte Butterworth-Pool
• Phone: 01172180030
• Email: Charlotte.Butterworth-Pool[@]xiros.co.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: September 2026
• Est. primary completion date: September 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Device:
• AchilloCordPLUS™ System Implant
AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair

Locations

Country	Name	City	State
United Kingdom	North Cumbria Integrated Care Nhs Foundation Trust	Penrith

Sponsors (1)

Lead Sponsor	Collaborator
Xiros Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Achilles Tendon Rupture Score (ATRS)	Change in ATRS Score 0-100 0=major limitations 100=no limitations	6 months
Primary	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	Achilles Tendon Rupture Score (ATRS)	Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations	2 years
Secondary	Length of time to unaided full weight bearing	Length of time to defined as removal of heel raise and walking unaided	2 years
Secondary	return to work and return to sport.	Time for patients to return to work and return to sport.	2 years
Secondary	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
Secondary	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
Secondary	Tegner Activity Scale	Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension)	2 years
Secondary	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
Secondary	Calf Circumference	Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side.	6 months
Secondary	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