Patients With an Acute Achilles Tendon RuptureSTAPONCT07914153
Early Functional Outcomes After Open Versus Percutaneous Repair of Acute Achilles Tendon Ruptures
A study testing Percutaneous Surgical Repair of Acute Achilles Tendon Rupture and Open Surgical Repair of Acute Achilles Tendon Rupture in people with Patients With an Acute Achilles Tendon Rupture and Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
This study aims to compare early functional outcomes and postoperative complications following open versus percutaneous repair of acute Achilles tendon ruptures in patients younger than 55 years admitted to Hautepierre Hospital. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
- What is being tested?
- Percutaneous Surgical Repair of Acute Achilles Tendon Rupture and Open Surgical Repair of Acute Achilles Tendon Rupture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients aged 18 to 55 years, inclusive.
- Patients with an Achilles tendon rupture diagnosed clinically and confirmed by imaging (ultrasound or magnetic resonance imaging [MRI]) when necessary.
- Patients for whom surgical management has been decided by a multidisciplinary trauma team meeting.
- Time between Achilles tendon rupture and surgery of less than 2 weeks.
- Patients able to understand the objectives and risks of the study and to provide dated and signed informed consent.
- Patients affiliated with, or beneficiaries of, a social security system.
Who cannot join
- Corticosteroid or platelet-rich plasma (PRP) injection in the vicinity of the Achilles tendon within 6 months before the Achilles tendon rupture.
- Chronic Achilles tendinopathy.
- History of a previous nonoperatively treated ipsilateral Achilles tendon rupture.
- History of ipsilateral Achilles tendon surgery.
- Use of a walking aid before the Achilles tendon rupture.
- American Society of Anesthesiologists (ASA) Physical Status Classification of III or higher.
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- Skin lesions in the surgical area (e.g., open wounds or abrasions).
- Inability to speak either English or French.
- Achilles tendon laceration caused by a sharp object.
- Patients under judicial protection or subject to a guardianship or curatorship measure.
- Inability to provide informed consent (e.g., emergency circumstances or difficulties understanding the study information).
- Patients subject to a legal protection measure, including curatorship, guardianship, a future protection mandate, or family authorization.
- Patients currently within an exclusion period from a previous study.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
DRCI Strasbourg, +33(0)3 88 11 67 11, monia.ben-hadj-hamed@chru-strasbourg.fr
Henri FAVREAU, Doctor
About this study
Official title: Comparison of Early Functional Outcomes Following Open Versus Percutaneous Surgical Repair of Acute Achilles Tendon Ruptures
This study aims to compare early functional outcomes and postoperative complications following open versus percutaneous repair of acute Achilles tendon ruptures in patients younger than 55 years admitted to Hautepierre Hospital. It will assess whether percutaneous repair reduces skin-related complications and whether open repair provides better early muscle strength recovery.
Read the detailed description
Acute Achilles tendon rupture is a common injury that may require surgical treatment. Two main surgical techniques are used: open repair and percutaneous repair. Although both aim to restore tendon continuity and function, they may differ in terms of postoperative complications, muscle strength recovery, and functional rehabilitation.
The aim of this study is to compare early functional outcomes and postoperative complications following open versus percutaneous surgical repair of acute Achilles tendon ruptures. The study hypothesizes that percutaneous repair may reduce skin-related complications, including delayed wound healing and surgical site infection, whereas open repair may provide better early recovery of muscle strength and facilitate rehabilitation.
The study will include patients younger than 55 years admitted to Hautepierre Hospital with an acute Achilles tendon rupture who meet the eligibility criteria and have no predefined exclusion criteria. The findings may help determine whether one surgical technique offers advantages over the other and contribute to optimizing the management of acute Achilles tendon ruptures.
- Conditions
- Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
- Being tested
- Percutaneous Surgical Repair of Acute Achilles Tendon Rupture, Open Surgical Repair of Acute Achilles Tendon Rupture
- Keywords
- acute Achilles tendon rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Surgical Repair of Acute Achilles Tendon RuptureProcedure or surgery
Surgical repair of an acute Achilles tendon rupture using a percutaneous technique.
Open Surgical Repair of Acute Achilles Tendon RuptureProcedure or surgery
Surgical repair of an acute Achilles tendon rupture using an open surgical technique.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Surgical Repair | Experimental | Participants with an acute Achilles tendon rupture randomized to undergo percutaneous surgical repair. Receives: Procedure: Percutaneous Surgical Repair of Acute Achilles Tendon Rupture |
| Open Surgical Repair | Active comparator | Participants with an acute Achilles tendon rupture randomized to undergo open surgical repair. Receives: Procedure: Open Surgical Repair of Acute Achilles Tendon Rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Achilles Tendon Total Rupture Score (ATRS) From 3 to 6 Months Postoperatively
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms and physical activity limitations following Achilles tendon rupture. The score ranges from 0 to 100 points, with higher scores indicating fewer symptoms and better function. The change in score will be calculated as the 6-month score minus the 3-month score and compared between the percutaneous surgery and open surgery groups.
Measured: 3 months and 6 months postoperatively.
Change in European Foot and Ankle Society (EFAS) Score From 3 to 6 Months Postoperatively
The European Foot and Ankle Society (EFAS) score is a patient-reported outcome measure assessing foot and ankle function. The score will be recorded using the questionnaire version specified in the study protocol, with a total score ranging from 0 to 40 points according to the study questionnaire. Higher scores indicate better function, provided this is consistent with the scoring instructions for the version used. The change in score will be calculated as the 6-month score minus the 3-month score and compared between the percutaneous surgery and open surgery groups.
Measured: 3 months and 6 months postoperatively.
Change in Return to Sport after Injury (RSI) Score From 3 to 6 Months Postoperatively
Psychological readiness to return to sport will be assessed using a 12-item patient-reported questionnaire administered at 3 and 6 months postoperatively. Each item is rated from 0 to 10, giving a maximum raw total score of 120 points. Higher scores indicate greater psychological readiness to return to sport. The change in score will be calculated as the 6-month score minus the 3-month score and compared between patients undergoing percutaneous surgery and those undergoing open surgery.
Measured: 3 months and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With an Acute Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henri FAVREAU, Doctor, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914153
- Sponsor's protocol ID
- 9523
- Other IDs
- 2025-A01288-41
- Acronym
- STAPO
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Study results may be disseminated through scientific publications and presentations, without disclosing personally identifiable information.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Functional Outcomes Following Open Versus Percutaneous Surgical Repair of Acute Achilles Tendon Ruptures
- ClinicalTrials.gov ID
- NCT07914153
- Acronym / sponsor ID
- STAPO / 9523
- Conditions
- Patients With an Acute Achilles Tendon Rupture, Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks
- Keywords
- acute Achilles tendon rupture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 3 Nov 2026 (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 study aims to compare early functional outcomes and postoperative complications following open versus percutaneous repair of acute Achilles tendon ruptures in patients younger than 55 years admitted to Hautepierre Hospital. It will assess whether percutaneous repair reduces skin-related complications and whether open repair provides better early muscle strength recovery.
Detailed description
Acute Achilles tendon rupture is a common injury that may require surgical treatment. Two main surgical techniques are used: open repair and percutaneous repair. Although both aim to restore tendon continuity and function, they may differ in terms of postoperative complications, muscle strength recovery, and functional rehabilitation.
The aim of this study is to compare early functional outcomes and postoperative complications following open versus percutaneous surgical repair of acute Achilles tendon ruptures. The study hypothesizes that percutaneous repair may reduce skin-related complications, including delayed wound healing and surgical site infection, whereas open repair may provide better early recovery of muscle strength and facilitate rehabilitation.
The study will include patients younger than 55 years admitted to Hautepierre Hospital with an acute Achilles tendon rupture who meet the eligibility criteria and have no predefined exclusion criteria. The findings may help determine whether one surgical technique offers advantages over the other and contribute to optimizing the management of acute Achilles tendon ruptures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Surgical Repair | Experimental | Procedure: Percutaneous Surgical Repair of Acute Achilles Tendon RuptureParticipants with an acute Achilles tendon rupture randomized to undergo percutaneous surgical repair. |
| Open Surgical Repair | Active comparator | Procedure: Open Surgical Repair of Acute Achilles Tendon RuptureParticipants with an acute Achilles tendon rupture randomized to undergo open surgical repair. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 to 55 years, inclusive.
- Patients with an Achilles tendon rupture diagnosed clinically and confirmed by imaging (ultrasound or magnetic resonance imaging [MRI]) when necessary.
- Patients for whom surgical management has been decided by a multidisciplinary trauma team meeting.
- Time between Achilles tendon rupture and surgery of less than 2 weeks.
- Patients able to understand the objectives and risks of the study and to provide dated and signed informed consent.
Key exclusion criteria (14 listed)
- Corticosteroid or platelet-rich plasma (PRP) injection in the vicinity of the Achilles tendon within 6 months before the Achilles tendon rupture.
- Chronic Achilles tendinopathy.
- History of a previous nonoperatively treated ipsilateral Achilles tendon rupture.
- History of ipsilateral Achilles tendon surgery.
- Use of a walking aid before the Achilles tendon rupture.
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 |
|---|---|---|
| Percutaneous Surgical Repair of Acute Achilles Tendon RuptureSurgical repair of an acute Achilles tendon rupture using a percutaneous technique. | Procedure or surgery | Percutaneous Surgical Repair |
| Open Surgical Repair of Acute Achilles Tendon RuptureSurgical repair of an acute Achilles tendon rupture using an open surgical technique. | Procedure or surgery | Open Surgical Repair |
Primary outcome
Change in Achilles Tendon Total Rupture Score (ATRS) From 3 to 6 Months Postoperatively
Time frame: 3 months and 6 months postoperatively.
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms and physical activity limitations following Achilles tendon rupture. The score ranges from 0 to 100 points, with higher scores indicating fewer symptoms and better function. The change in score will be calculated as the 6-month score minus the 3-month score and compared between the percutaneous surgery and open surgery groups.
Change in European Foot and Ankle Society (EFAS) Score From 3 to 6 Months Postoperatively
Time frame: 3 months and 6 months postoperatively.
The European Foot and Ankle Society (EFAS) score is a patient-reported outcome measure assessing foot and ankle function. The score will be recorded using the questionnaire version specified in the study protocol, with a total score ranging from 0 to 40 points according to the study questionnaire. Higher scores indicate better function, provided this is consistent with the scoring instructions for the version used. The change in score will be calculated as the 6-month score minus the 3-month score and compared between the percutaneous surgery and open surgery groups.
Change in Return to Sport after Injury (RSI) Score From 3 to 6 Months Postoperatively
Time frame: 3 months and 6 months postoperatively
Psychological readiness to return to sport will be assessed using a 12-item patient-reported questionnaire administered at 3 and 6 months postoperatively. Each item is rated from 0 to 10, giving a maximum raw total score of 120 points. Higher scores indicate greater psychological readiness to return to sport. The change in score will be calculated as the 6-month score minus the 3-month score and compared between patients undergoing percutaneous surgery and those undergoing open surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Study results may be disseminated through scientific publications and presentations, without disclosing personally identifiable information.
Related trials for Patients With an Acute Achilles Tendon Rupture
Recruiting
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Achilles Tendon Rupture
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.
Henri FAVREAU, Doctor principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Surgical Repair of Acute Achilles Tendon Rupture and Open Surgical Repair of Acute Achilles Tendon Rupture in people with Patients With an Acute Achilles Tendon Rupture and Time From Achilles Tendon Rupture to Surgery of Less Than 2 Weeks, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 3 Nov 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monia BEN HADJ HAMED (+33(0)3 88 11 67 11, monia.ben-hadj-hamed@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Achilles Tendon Total Rupture Score (ATRS) From 3 to 6 Months Postoperatively (time frame: 3 months and 6 months postoperatively.). The study lists 3 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 3 Nov 2026.