Acute Achilles Tendon RuptureNCT07312097
Could Conservative Treatment Become the New Gold Standard in Achilles Tendon Ruptures?
A study testing Conservative treatment and Surgical Repair in people with Acute Achilles Tendon Rupture, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare conservative and surgical treatments for acute Achilles tendon rupture. Forty-four patients were randomly assigned to either a conservative rehabilitation protocol or open surgical repair. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Achilles Tendon Rupture
- What is being tested?
- Conservative treatment and Surgical Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2023to 20 Dec 2024
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-50 years
- Acute complete Achilles tendon rupture (tendon-to-tendon)
- Injury occurred within 3 weeks prior to presentation
- Willingness and ability to comply with the functional rehabilitation program
Who cannot join
- Injury occurred more than 3 weeks prior to presentation
- Open Achilles tendon rupture
- History of preexisting foot or ankle pathology
- Musculotendinous, insertional, or calcaneal avulsion-type Achilles tendon injuries
- Presence of additional risk factors increasing Achilles tendon injury risk (e.g., diabetes mellitus, immunosuppressive therapy, fluoroquinolone use, or systemic corticosteroid use)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Haseki Training and Research Hospital, 34265
About this study
Official title: Could Conservative Treatment Become the New Gold Standard in the Treatment of Acute Achilles Tendon Ruptures: A Prospective Randomized Controlled Trial
This study aims to compare conservative and surgical treatments for acute Achilles tendon rupture. Forty-four patients were randomly assigned to either a conservative rehabilitation protocol or open surgical repair. Functional outcomes were evaluated using isokinetic muscle strength testing and clinical scoring systems such as the ATRS, AOFAS, FADI, VAS, and Leppilahti scores.
The results showed no significant difference between the two groups in terms of strength, tendon length, or clinical outcomes. Rerupture rates were similar, while wound complications occurred only in the surgical group.
The findings suggest that conservative treatment combined with early functional rehabilitation can provide outcomes comparable to surgery, with fewer complications. Conservative treatment may be a safe and effective alternative for managing acute Achilles tendon ruptures.
Read the detailed description
Achilles tendon rupture is a common sports-related injury, and the optimal treatment approach remains controversial. Surgical repair has traditionally been considered the gold standard due to lower rerupture rates and better restoration of tendon continuity. However, surgery carries risks such as wound infection, nerve injury, and postoperative complications.
Recent advances in rehabilitation techniques have led to renewed interest in conservative management, which allows for early mobilization and functional recovery without surgical risks. This study was designed as a prospective, randomized clinical trial to objectively compare conservative and surgical treatments for acute Achilles tendon rupture.
Forty-four patients were randomly allocated to either a conservative treatment protocol based on the GAPNOT early functional rehabilitation model or open surgical repair using the Krackow suture technique. Functional recovery was assessed using isokinetic muscle testing for plantar flexion and dorsiflexion strength, as well as validated clinical scoring systems (ATRS, AOFAS, FADI, VAS, and Leppilahti).
The primary objective of this study is to determine whether conservative treatment can achieve comparable functional and biomechanical outcomes to surgical repair while minimizing complications. The results are expected to contribute to establishing evidence-based treatment guidelines and may support conservative management as a new gold standard in selected patient populations.
- Conditions
- Acute Achilles Tendon Rupture
- Being tested
- Conservative treatment, Surgical Repair
- Keywords
- achilles tendon rupture, Isokinetic strength, Functional rehabilitation, conservative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatmentOther
Participants follow the GAPNOT functional rehabilitation protocol. Initially immobilized in maximum plantar flexion with non-weight-bearing. At 2 weeks partial weight-bearing is allowed with an Achilles boot and heel lifts; by weeks 4-6 weight-bearing is increased and supervised physiotherapy is initiated focusing on plantar flexion strength, calf strengthening and ankle range of motion. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores.
Surgical RepairProcedure or surgery
Participants undergo open end-to-end Achilles tendon repair using the locked Krackow suture technique with 2-0 FiberWire and epitendinous augmentation. Postoperatively, standardized early functional rehabilitation is applied including gradual weight-bearing, ankle mobilization and physiotherapy focused on plantar flexion strength and ROM. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores.
| Study group | Role | What they receive |
|---|---|---|
| Conservative Treatment | Active comparator | Participants follow the GAPNOT functional rehabilitation protocol, including initial immobilization in plantar flexion, gradual partial to full weight-bearing, and supervised physiotherapy to improve plantar flexion strength and ankle range of motion. Receives: Other: Conservative treatment |
| Surgical Repair | Active comparator | Open end-to-end Achilles tendon repair using the locked Krackow suture technique, followed by epitendinous augmentation and standardized early functional rehabilitation including gradual weight-bearing and physiotherapy. Receives: Procedure: Surgical Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plantar Flexion Torque
Peak plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Measured: 12-18 months post-injury
Total Work During Plantar Flexion
Total work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Measured: 12-18 months post-injury
Initial Plantar Flexion Torque
Initial plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity
Measured: 12-18 months post-injury
Secondary outcomes (6)
Achilles Tendon Resting Angle (ATRA)
Achilles tendon resting angle (degrees) measured using a standardized clinical goniometric method.
Measured: 12-18 months post-injury
Pain Intensity (VAS)
Pain intensity measured using the Visual Analog Scale (VAS), reported on a 0-10 scale
Measured: 12-18 months post-injury
Leppilahti Achilles tendon rupture score
Leppilahti Achilles tendon rupture score (points) measured using the standardized Leppilahti scoring system.
Measured: 12-18 months post-injury
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score (points) measured using the standardized AOFAS scoring system
Measured: 12-18 months post-injury
Foot and Ankle Disability Index (FADI)
Foot and ankle function measured using the Foot and Ankle Disability Index (FADI), reported as a numerical score (points)
Measured: 12-18 months post-injury
Rerupture Rate
Achilles tendon rerupture determined by clinical examination and/or imaging confirmation and recorded as the number of participants experiencing rerupture.
Measured: 12-18 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start20 Aug 2023
- Primary completion20 Feb 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were allocated in a 1:1 ratio to either the conservative treatment group or the surgical repair group using a parallel assignment model. Both groups received standardized early functional rehabilitation protocols specific to their treatment type, and outcomes were compared after a minimum 12-month follow-up.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312097
- Sponsor's protocol ID
- 113-2023
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The decision is based on patient confidentiality, ethical considerations, and the study's informed consent process, which did not include provisions for data sharing with external researchers
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Conservative Treatment Become the New Gold Standard in the Treatment of Acute Achilles Tendon Ruptures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07312097
- Acronym / sponsor ID
- 113-2023
- Conditions
- Acute Achilles Tendon Rupture
- Keywords
- achilles tendon rupture, Isokinetic strength, Functional rehabilitation, conservative treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Aug 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 31 Dec 2025 (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 conservative and surgical treatments for acute Achilles tendon rupture. Forty-four patients were randomly assigned to either a conservative rehabilitation protocol or open surgical repair. Functional outcomes were evaluated using isokinetic muscle strength testing and clinical scoring systems such as the ATRS, AOFAS, FADI, VAS, and Leppilahti scores.
The results showed no significant difference between the two groups in terms of strength, tendon length, or clinical outcomes. Rerupture rates were similar, while wound complications occurred only in the surgical group.
The findings suggest that conservative treatment combined with early functional rehabilitation can provide outcomes comparable to surgery, with fewer complications. Conservative treatment may be a safe and effective alternative for managing acute Achilles tendon ruptures.
Detailed description
Achilles tendon rupture is a common sports-related injury, and the optimal treatment approach remains controversial. Surgical repair has traditionally been considered the gold standard due to lower rerupture rates and better restoration of tendon continuity. However, surgery carries risks such as wound infection, nerve injury, and postoperative complications.
Recent advances in rehabilitation techniques have led to renewed interest in conservative management, which allows for early mobilization and functional recovery without surgical risks. This study was designed as a prospective, randomized clinical trial to objectively compare conservative and surgical treatments for acute Achilles tendon rupture.
Forty-four patients were randomly allocated to either a conservative treatment protocol based on the GAPNOT early functional rehabilitation model or open surgical repair using the Krackow suture technique. Functional recovery was assessed using isokinetic muscle testing for plantar flexion and dorsiflexion strength, as well as validated clinical scoring systems (ATRS, AOFAS, FADI, VAS, and Leppilahti).
The primary objective of this study is to determine whether conservative treatment can achieve comparable functional and biomechanical outcomes to surgical repair while minimizing complications. The results are expected to contribute to establishing evidence-based treatment guidelines and may support conservative management as a new gold standard in selected patient populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were allocated in a 1:1 ratio to either the conservative treatment group or the surgical repair group using a parallel assignment model. Both groups received standardized early functional rehabilitation protocols specific to their treatment type, and outcomes were compared after a minimum 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Conservative Treatment | Active comparator | Other: Conservative treatmentParticipants follow the GAPNOT functional rehabilitation protocol, including initial immobilization in plantar flexion, gradual partial to full weight-bearing, and supervised physiotherapy to improve plantar flexion strength and ankle range of motion. |
| Surgical Repair | Active comparator | Procedure: Surgical RepairOpen end-to-end Achilles tendon repair using the locked Krackow suture technique, followed by epitendinous augmentation and standardized early functional rehabilitation including gradual weight-bearing and physiotherapy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18-50 years
- Acute complete Achilles tendon rupture (tendon-to-tendon)
- Injury occurred within 3 weeks prior to presentation
- Willingness and ability to comply with the functional rehabilitation program
Key exclusion criteria (5 listed)
- Injury occurred more than 3 weeks prior to presentation
- Open Achilles tendon rupture
- History of preexisting foot or ankle pathology
- Musculotendinous, insertional, or calcaneal avulsion-type Achilles tendon injuries
- Presence of additional risk factors increasing Achilles tendon injury risk (e.g., diabetes mellitus, immunosuppressive therapy, fluoroquinolone use, or systemic corticosteroid use)
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 |
|---|---|---|
| Conservative treatmentParticipants follow the GAPNOT functional rehabilitation protocol. Initially immobilized in maximum plantar flexion with non-weight-bearing. At 2 weeks partial weight-bearing is allowed with an Achilles boot and heel lifts; by weeks 4-6 weight-bearing is increased and supervised physiotherapy is initiated focusing on plantar flexion strength, calf strengthening and ankle range of motion. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores. | Other | Conservative Treatment |
| Surgical RepairParticipants undergo open end-to-end Achilles tendon repair using the locked Krackow suture technique with 2-0 FiberWire and epitendinous augmentation. Postoperatively, standardized early functional rehabilitation is applied including gradual weight-bearing, ankle mobilization and physiotherapy focused on plantar flexion strength and ROM. Outcomes assessed at 12-18 months by isokinetic testing and clinical scores. | Procedure or surgery | Surgical Repair |
Primary outcome
Peak Plantar Flexion Torque
Time frame: 12-18 months post-injury
Peak plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Total Work During Plantar Flexion
Time frame: 12-18 months post-injury
Total work during plantar flexion (Joules) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity.
Initial Plantar Flexion Torque
Time frame: 12-18 months post-injury
Initial plantar flexion torque (Newton-meters, Nm) measured using an isokinetic dynamometer (HUMAC NORM 2015) at a standardized angular velocity
6 secondary outcomes
Achilles Tendon Resting Angle (ATRA)
Time frame: 12-18 months post-injury
Pain Intensity (VAS)
Time frame: 12-18 months post-injury
Leppilahti Achilles tendon rupture score
Time frame: 12-18 months post-injury
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
Time frame: 12-18 months post-injury
Foot and Ankle Disability Index (FADI)
Time frame: 12-18 months post-injury
Rerupture Rate
Time frame: 12-18 months post-injury
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 31 Dec 2025.
- Official website of Haseki Training and Research Hospital, where the study on conservative versus operative treatment of acute Achilles tendon rupture was conducted. Provides hospital information and contact details for study-related queries.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The decision is based on patient confidentiality, ethical considerations, and the study's informed consent process, which did not include provisions for data sharing with external researchers
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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?
A study testing Conservative treatment and Surgical Repair in people with Acute Achilles Tendon Rupture, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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 31 Dec 2025. 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 Turkey (Türkiye). 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?
Peak Plantar Flexion Torque (time frame: 12-18 months post-injury). 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 31 Dec 2025.