Achilles Tendon RuptureNCT05304819
PMCF Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
An observational study of Achilles Tendon Rupture, run by Xiros Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- AchilloCordPLUS™ System Implant
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2022to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring end to end repair for acute Achilles tendon rupture.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Cumbria Integrated Care Nhs Foundation Trust
Penrith, CA11 7BF
About this study
Official title: 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 UKCA-Marked device manufactured by Xiros Ltd.
Read the 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.
- Conditions
- Achilles Tendon Rupture
- Being tested
- AchilloCordPLUS™ System Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AchilloCordPLUS™ System ImplantDevice
AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
| Study group | Role | What they receive |
|---|---|---|
| AchilloCordPLUS | End to end repair for acute Achilles tendon rupture with AchilloCordPLUS Receives: Device: AchilloCordPLUS™ System Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles Tendon Rupture Score (ATRS)
Change in ATRS Score 0-100 0=major limitations 100=no limitations
Measured: 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).
Measured: 6 months
Secondary outcomes (9)
Achilles Tendon Rupture Score (ATRS)
Change ATRS Score from baseline upto 2 years in 0-100 0=major limitations 100=no limitations
Measured: 2 years
Length of time to unaided full weight bearing
Length of time to defined as removal of heel raise and walking unaided
Measured: 2 years
return to work and return to sport.
Time for patients to return to work and return to sport.
Measured: 2 years
Tegner Activity Scale (pre-injury)
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)
Measured: 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
Measured: 2 years
Tegner Activity Scale (baseline)
Change from Tegner score from baseline to 2 years 10 (competitive sport) 0 (sick leave or disability pension)
Measured: 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.
Measured: 6 months
Calf Circumference
Change in calf circumference from 6 weeks up to 6 months and compare to the contralateral side.
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start9 Mar 2022
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiros Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304819
- Sponsor's protocol ID
- CRE 029
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up (PMCF) Study of the AchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair
- ClinicalTrials.gov ID
- NCT05304819
- Acronym / sponsor ID
- CRE 029
- Conditions
- Achilles Tendon Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Xiros LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AchilloCordPLUS | – | Device: AchilloCordPLUS™ System ImplantEnd to end repair for acute Achilles tendon rupture with AchilloCordPLUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring end to end repair for acute Achilles tendon rupture.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AchilloCordPLUS™ System ImplantAchilloCordPLUS System Implant Set for Acute Achilles Tendon Repair | Device | AchilloCordPLUS |
Primary outcome
Achilles Tendon Rupture Score (ATRS)
Time frame: 6 months
Change in ATRS Score 0-100 0=major limitations 100=no limitations
adverse events (AE)
Time frame: 6 months
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).
9 secondary outcomes
Achilles Tendon Rupture Score (ATRS)
Time frame: 2 years
Length of time to unaided full weight bearing
Time frame: 2 years
return to work and return to sport.
Time frame: 2 years
Tegner Activity Scale (pre-injury)
Time frame: 2 years
RAND Short Form 36 (SF 36) V1
Time frame: 2 years
Tegner Activity Scale (baseline)
Time frame: 2 years
Range of Motion
Time frame: 6 months
Calf Circumference
Time frame: 6 months
Adverse Event
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Achilles Tendon Rupture, run by Xiros Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles Tendon Rupture Score (ATRS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.