Achilles Tendon Repairs/reconstructionsNCT06847971
Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect
A study testing Flexor hallucis longus tendon transfer and Gastrocnemius augmented Flexor hallucis longus tendon transfer in people with Achilles Tendon Repairs/reconstructions and Achilles Tendon Rupture, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare the functional outcome of Isolated Flexor hallucis longus tendon transfer and Gastrocnemius Augmented Flexor hallucis longus tendon transfer in repair of Achilles tendon defects. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Achilles Tendon Repairs/reconstructions, Achilles Tendon Rupture
- What is being tested?
- Flexor hallucis longus tendon transfer and Gastrocnemius augmented Flexor hallucis longus tendon transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Jun 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range: Adolescents and adults with skeletally mature feet (above 12 y in females and 14 years in males).
- Achilles Tendon defects more than 4 cm resulted from acute or chronic rupture, post-debridement defects in case of neglected insertional tendinopathy, spontaneous ruptures due to tendinosis or after tumor resection.
Who cannot join
- General medical contraindications to surgical interventions
- Calcaneal Fracture, subtalar fusion
- infection or previous surgery in the ipsilateral hindfoot or ankle
- Systemic disease including seronegative inflammatory diseases, spondyloarthropathies or sarcoidosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Isolated Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect: a Randomized Controlled Trial
This study aims to compare the functional outcome of Isolated Flexor hallucis longus tendon transfer and Gastrocnemius Augmented Flexor hallucis longus tendon transfer in repair of Achilles tendon defects. Also, compare the two procedures regarding complication rate, time to restore the function, and the need for secondary procedures.
Read the detailed description
The Achilles tendon (AT) is the largest and strongest tendon in the human body, yet it is also one of the most commonly ruptured tendons, with an annual incidence of about 18 cases per 100,000 people. Around 75% of Achilles tendon ruptures (ATR) occur in middle-aged patients during sports activity or following trauma. These injuries typically happen in a region 2 to 6 cm above the tendon's attachment to the heel, an area that has a relatively poor blood supply, that reducing the probability of the healing of the tendon by conservative management. Because of the absence of significant pain and the ability to partially maintain plantar flexion, it has been reported that around 10-25% of Achilles tendon rupture (ATR) cases are overlooked or misdiagnosed during the initial medical assessment. The delaying of the diagnosis and by the way the treatment results in a greater separation between the tendon ends, with scar tissue filling the gap leading to lengthening to the gastrocnemius muscle decreasing its tensile forces. This makes the surgical intervention for repair of chronic tendo Achillis rupture necessary to restore normal leg function. Various surgical procedures such as reconstruction with V-Y advanced flap, gastrocnemius turn-down flap, local tendon transfer augments (Flexor hallucis longus (FHL) or peroneus brevis), semitendinosus autograft, free tissue transfer including synthetic grafts and allografts to bridge the gap have been described. Some techniques have been combined, such as tissue advancement and tendon transfer. Multiple studies have been done comparing two or more of the mentioned techniques, but to our knowledge there is no randomized controlled study comparing the isolated FHL tendon transfer to gastrocnemius augmented flexor hallucis longus (GAFHL) tendon transfer.
- Being tested
- Flexor hallucis longus tendon transfer, Gastrocnemius augmented Flexor hallucis longus tendon transfer
- Keywords
- Achilles tendon rupture, flexor hallucis longus, gastrocnemius augmentation, Achilles tendon repairs/reconstructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexor hallucis longus tendon transferProcedure or surgery
The FHL tendon will be dissected and transected as far distally as possible. The FHL tendon will be transfixed by Krakow's suture being inserted into the distal 3 cm in the stump to ensure adequate length of the graft inserted within the bony tunnel in the calcaneus.A guide wire with eyelet will be inserted in the calcaneum just anterior to the native AT insertion by a distance 2 mm more than the half of the diameter of the transferred tendon to avoid blow up of the posterior wall of the tunnel. A tunnel will be drilled over the guide wire according to the tendon thickness, without penetrating the planter surface of the calcaneum. The threads at the end of FHL tendon suture will be passed through the eyelet of the guide wire. The tendon will be driven into the calcaneal bony tunnel by pulling the guide wire through the plantar aspect of the heel. Then the FHL tendon will be tenodesed into the bone tunnel using a interference screw of the same size or 1 mm larger than the bone tunnel.
Gastrocnemius augmented Flexor hallucis longus tendon transferProcedure or surgery
The gastrocnemius tendon will be refixed to the calcaneal tuberosity using anchors. According to the size of the defect: If the size of the gap was 4-5 cm, an additional gastrocnemius turndown or V-Y flaps will be done. Turn down flap will be achieved by creating 2 cm wide and 5-6 cm long flap from the gastrocnemius tendon. The most distal 1 cm from the proximal stump will be secured along the lateral border of the flap to prevent its separation from the original stump during tensioning and fixation to the calcaneus. V-Y flap will be achieved by having inverted V-shaped incision in the distal part of the gastrocnemius starting proximally and extending the two limbs distally leaving the lateral 1 cm from the original tendon. Then carful advancement of the proximal AT stump distally to reach the calcaneal tuberosity. then Fixation will be achieved by suture anchors. If more than 5 cm gap, tenomyodesis of FHL through the proximal stump of Gastrocnemius muscle will be done.
| Study group | Role | What they receive |
|---|---|---|
| Flexor hallucis longus tendon transfer | Active comparator | Achilles tendon defects repair will be done by flexor hallucis longus tendon transfer only. Receives: Procedure: Flexor hallucis longus tendon transfer |
| Gastrocnemius augmented flexor hallucis longus tendon transfer | Active comparator | Achilles tendon defect repair by gastrocnemius augmentation plus flexor hallucis longus tendon transfer Receives: Procedure: Gastrocnemius augmented Flexor hallucis longus tendon transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale
A scale for assessing the functional status of the ankle and hindfoot. It evaluates both subjective and objective components, including pain, function, alignment, and range of motion. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, and interpreted as: Excellent: 90-100 Good: 80-89 Fair: 70-79 Poor: ≤69
Measured: at 6 months, and 1 year follow up visits
Strength Testing with handheld Dynamometry for plantar flexors
Isometric plantar flexion against consistent resistance with the strength measured in Newtons.
Measured: At 3 months, 6 months, and one year follow up visits.
Secondary outcomes (2)
Rate of complications
wound healing complications, post-operative infections, nerve injuries, and tendon re-rupture.
Measured: Through study completion, an average of 1 year
Foot function index
Foot function index included 17 questions, covering three sub-scales of foot function: Pain, Disability, and Activity Limitation. Scoring for the Foot Function is based on a visual analog scale with 10 intervals. Scores are calculated for each of the sub-scales, as well as a total score (average of all sub-scales). Scores may be represented both as a raw score and a percentage. Higher scores indicate worsening foot health and poorer foot-related quality of life. The score ranges from 0 to 170 with 0 being the best regarding foot function and 170 the worst regarding foot function.
Measured: at 6 months, and 1 year follow up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study startJun 2025 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon Repairs/reconstructionsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moaiadeldin Ahmed Mohamed Ahmed Abdelmawla, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847971
- Sponsor's protocol ID
- FHLTT VS GAFHLTT in ATD
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guclu B, Basat HC, Yildirim T, Bozduman O, Us AK. Long-term Results of Chronic Achilles Tendon Ruptures Repaired With V-Y Tendon Plasty and Fascia Turndown. Foot Ankle Int. 2016 Jul;37(7):737-42. doi: 10.1177/1071100716642753. Epub 2016 Apr 1.
PubMed 27036138Nilsson N, Gunnarsson B, Carmont MR, Brorsson A, Karlsson J, Nilsson Helander K. Endoscopically assisted reconstruction of chronic Achilles tendon ruptures and re-ruptures using a semitendinosus autograft is a viable alternative to pre-existing techniques. Knee Surg Sports Traumatol Arthrosc. 2022 Jul;30(7):2477-2484. doi: 10.1007/s00167-022-06943-2. Epub 2022 Apr 9.
PubMed 35396938Padanilam TG. Chronic Achilles tendon ruptures. Foot Ankle Clin. 2009 Dec;14(4):711-28. doi: 10.1016/j.fcl.2009.08.001.
PubMed 19857844Gabel S, Manoli A 2nd. Neglected rupture of the Achilles tendon. Foot Ankle Int. 1994 Sep;15(9):512-7. doi: 10.1177/107110079401500912.
PubMed 7820247Kraeutler MJ, Purcell JM, Hunt KJ. Chronic Achilles Tendon Ruptures. Foot Ankle Int. 2017 Aug;38(8):921-929. doi: 10.1177/1071100717709570. Epub 2017 May 29. No abstract available.
PubMed 28553729Abraham E, Pankovich AM. Neglected rupture of the Achilles tendon. Treatment by V-Y tendinous flap. J Bone Joint Surg Am. 1975 Mar;57(2):253-5.
PubMed 1089672Kann JN, Myerson MS. Surgical management of chronic ruptures of the Achilles tendon. Foot and ankle clinics. 1997;2(3):535-45.
Cetti R, Junge J, Vyberg M. Spontaneous rupture of the Achilles tendon is preceded by widespread and bilateral tendon damage and ipsilateral inflammation: a clinical and histopathologic study of 60 patients. Acta Orthop Scand. 2003 Feb;74(1):78-84. doi: 10.1080/00016470310013707.
PubMed 12635798Leslie HD, Edwards WH. Neglected ruptures of the Achilles tendon. Foot Ankle Clin. 2005 Jun;10(2):357-70. doi: 10.1016/j.fcl.2005.01.009.
PubMed 15922924Abubeih H, Khaled M, Saleh WR, Said GZ. Flexor hallucis longus transfer clinical outcome through a single incision for chronic Achilles tendon rupture. Int Orthop. 2018 Nov;42(11):2699-2704. doi: 10.1007/s00264-018-3976-x. Epub 2018 May 12.
PubMed 29754186Maffulli N, Waterston SW, Squair J, Reaper J, Douglas AS. Changing incidence of Achilles tendon rupture in Scotland: a 15-year study. Clin J Sport Med. 1999 Jul;9(3):157-60. doi: 10.1097/00042752-199907000-00007.
PubMed 10512344Leppilahti J, Puranen J, Orava S. Incidence of Achilles tendon rupture. Acta Orthop Scand. 1996 Jun;67(3):277-9. doi: 10.3109/17453679608994688.
PubMed 8686468
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Flexor Hallucis Longus Tendon Transfer VS Gastrocnemius Augmented Flexor Hallucis Longus Tendon Transfer in Management of Achilles Tendon Defect: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06847971
- Acronym / sponsor ID
- FHLTT VS GAFHLTT in ATD
- Keywords
- Achilles tendon rupture, flexor hallucis longus, gastrocnemius augmentation, Achilles tendon repairs/reconstructions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Feb 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 the functional outcome of Isolated Flexor hallucis longus tendon transfer and Gastrocnemius Augmented Flexor hallucis longus tendon transfer in repair of Achilles tendon defects. Also, compare the two procedures regarding complication rate, time to restore the function, and the need for secondary procedures.
Detailed description
The Achilles tendon (AT) is the largest and strongest tendon in the human body, yet it is also one of the most commonly ruptured tendons, with an annual incidence of about 18 cases per 100,000 people. Around 75% of Achilles tendon ruptures (ATR) occur in middle-aged patients during sports activity or following trauma. These injuries typically happen in a region 2 to 6 cm above the tendon's attachment to the heel, an area that has a relatively poor blood supply, that reducing the probability of the healing of the tendon by conservative management. Because of the absence of significant pain and the ability to partially maintain plantar flexion, it has been reported that around 10-25% of Achilles tendon rupture (ATR) cases are overlooked or misdiagnosed during the initial medical assessment. The delaying of the diagnosis and by the way the treatment results in a greater separation between the tendon ends, with scar tissue filling the gap leading to lengthening to the gastrocnemius muscle decreasing its tensile forces. This makes the surgical intervention for repair of chronic tendo Achillis rupture necessary to restore normal leg function. Various surgical procedures such as reconstruction with V-Y advanced flap, gastrocnemius turn-down flap, local tendon transfer augments (Flexor hallucis longus (FHL) or peroneus brevis), semitendinosus autograft, free tissue transfer including synthetic grafts and allografts to bridge the gap have been described. Some techniques have been combined, such as tissue advancement and tendon transfer. Multiple studies have been done comparing two or more of the mentioned techniques, but to our knowledge there is no randomized controlled study comparing the isolated FHL tendon transfer to gastrocnemius augmented flexor hallucis longus (GAFHL) tendon transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flexor hallucis longus tendon transfer | Active comparator | Procedure: Flexor hallucis longus tendon transferAchilles tendon defects repair will be done by flexor hallucis longus tendon transfer only. |
| Gastrocnemius augmented flexor hallucis longus tendon transfer | Active comparator | Procedure: Gastrocnemius augmented Flexor hallucis longus tendon transferAchilles tendon defect repair by gastrocnemius augmentation plus flexor hallucis longus tendon transfer |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age range: Adolescents and adults with skeletally mature feet (above 12 y in females and 14 years in males).
- Achilles Tendon defects more than 4 cm resulted from acute or chronic rupture, post-debridement defects in case of neglected insertional tendinopathy, spontaneous ruptures due to tendinosis or after tumor resection.
Key exclusion criteria (4 listed)
- General medical contraindications to surgical interventions
- Calcaneal Fracture, subtalar fusion
- infection or previous surgery in the ipsilateral hindfoot or ankle
- Systemic disease including seronegative inflammatory diseases, spondyloarthropathies or sarcoidosis.
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 |
|---|---|---|
| Flexor hallucis longus tendon transferThe FHL tendon will be dissected and transected as far distally as possible. The FHL tendon will be transfixed by Krakow's suture being inserted into the distal 3 cm in the stump to ensure adequate length of the graft inserted within the bony tunnel in the calcaneus.A guide wire with eyelet will be inserted in the calcaneum just anterior to the native AT insertion by a distance 2 mm more than the half of the diameter of the transferred tendon to avoid blow up of the posterior wall of the tunnel. A tunnel will be drilled over the guide wire according to the tendon thickness, without penetrating the planter surface of the calcaneum. The threads at the end of FHL tendon suture will be passed through the eyelet of the guide wire. The tendon will be driven into the calcaneal bony tunnel by pulling the guide wire through the plantar aspect of the heel. Then the FHL tendon will be tenodesed into the bone tunnel using a interference screw of the same size or 1 mm larger than the bone tunnel. | Procedure or surgery | Flexor hallucis longus tendon transfer |
| Gastrocnemius augmented Flexor hallucis longus tendon transferThe gastrocnemius tendon will be refixed to the calcaneal tuberosity using anchors. According to the size of the defect: If the size of the gap was 4-5 cm, an additional gastrocnemius turndown or V-Y flaps will be done. Turn down flap will be achieved by creating 2 cm wide and 5-6 cm long flap from the gastrocnemius tendon. The most distal 1 cm from the proximal stump will be secured along the lateral border of the flap to prevent its separation from the original stump during tensioning and fixation to the calcaneus. V-Y flap will be achieved by having inverted V-shaped incision in the distal part of the gastrocnemius starting proximally and extending the two limbs distally leaving the lateral 1 cm from the original tendon. Then carful advancement of the proximal AT stump distally to reach the calcaneal tuberosity. then Fixation will be achieved by suture anchors. If more than 5 cm gap, tenomyodesis of FHL through the proximal stump of Gastrocnemius muscle will be done. | Procedure or surgery | Gastrocnemius augmented flexor hallucis longus tendon transfer |
Primary outcome
American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale
Time frame: at 6 months, and 1 year follow up visits
A scale for assessing the functional status of the ankle and hindfoot. It evaluates both subjective and objective components, including pain, function, alignment, and range of motion. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, and interpreted as: Excellent: 90-100 Good: 80-89 Fair: 70-79 Poor: ≤69
Strength Testing with handheld Dynamometry for plantar flexors
Time frame: At 3 months, 6 months, and one year follow up visits.
Isometric plantar flexion against consistent resistance with the strength measured in Newtons.
2 secondary outcomes
Rate of complications
Time frame: Through study completion, an average of 1 year
Foot function index
Time frame: at 6 months, and 1 year follow up visits
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 26 Feb 2025.
- Background: PubMed 27036138Guclu B, Basat HC, Yildirim T, Bozduman O, Us AK. Long-term Results of Chronic Achilles Tendon Ruptures Repaired With V-Y Tendon Plasty and Fascia Turndown. Foot Ankle Int. 2016 Jul;37(7):737-42. doi: 10.1177/1071100716642753. Epub 2016 Apr 1.
- Background: PubMed 35396938Nilsson N, Gunnarsson B, Carmont MR, Brorsson A, Karlsson J, Nilsson Helander K. Endoscopically assisted reconstruction of chronic Achilles tendon ruptures and re-ruptures using a semitendinosus autograft is a viable alternative to pre-existing techniques. Knee Surg Sports Traumatol Arthrosc. 2022 Jul;30(7):2477-2484. doi: 10.1007/s00167-022-06943-2. Epub 2022 Apr 9.
- Background: PubMed 19857844Padanilam TG. Chronic Achilles tendon ruptures. Foot Ankle Clin. 2009 Dec;14(4):711-28. doi: 10.1016/j.fcl.2009.08.001.
- Background: PubMed 7820247Gabel S, Manoli A 2nd. Neglected rupture of the Achilles tendon. Foot Ankle Int. 1994 Sep;15(9):512-7. doi: 10.1177/107110079401500912.
- Background: PubMed 28553729Kraeutler MJ, Purcell JM, Hunt KJ. Chronic Achilles Tendon Ruptures. Foot Ankle Int. 2017 Aug;38(8):921-929. doi: 10.1177/1071100717709570. Epub 2017 May 29. No abstract available.
- Background: PubMed 1089672Abraham E, Pankovich AM. Neglected rupture of the Achilles tendon. Treatment by V-Y tendinous flap. J Bone Joint Surg Am. 1975 Mar;57(2):253-5.
- BackgroundKann JN, Myerson MS. Surgical management of chronic ruptures of the Achilles tendon. Foot and ankle clinics. 1997;2(3):535-45.
- Background: PubMed 12635798Cetti R, Junge J, Vyberg M. Spontaneous rupture of the Achilles tendon is preceded by widespread and bilateral tendon damage and ipsilateral inflammation: a clinical and histopathologic study of 60 patients. Acta Orthop Scand. 2003 Feb;74(1):78-84. doi: 10.1080/00016470310013707.
- Background: PubMed 15922924Leslie HD, Edwards WH. Neglected ruptures of the Achilles tendon. Foot Ankle Clin. 2005 Jun;10(2):357-70. doi: 10.1016/j.fcl.2005.01.009.
- Background: PubMed 29754186Abubeih H, Khaled M, Saleh WR, Said GZ. Flexor hallucis longus transfer clinical outcome through a single incision for chronic Achilles tendon rupture. Int Orthop. 2018 Nov;42(11):2699-2704. doi: 10.1007/s00264-018-3976-x. Epub 2018 May 12.
- Background: PubMed 10512344Maffulli N, Waterston SW, Squair J, Reaper J, Douglas AS. Changing incidence of Achilles tendon rupture in Scotland: a 15-year study. Clin J Sport Med. 1999 Jul;9(3):157-60. doi: 10.1097/00042752-199907000-00007.
- Background: PubMed 8686468Leppilahti J, Puranen J, Orava S. Incidence of Achilles tendon rupture. Acta Orthop Scand. 1996 Jun;67(3):277-9. doi: 10.3109/17453679608994688.
Related trials for Achilles Tendon Repairs/reconstructions
Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Tendon Tear, Tendinopathy
Active, not recruiting
Project Tendura: The Impact of Blood Flow Restriction Resistance Training (BFR-RT) in Patients With Achilles Tendon Rupture (ATR) Repair
Achilles Tendon Rupture, Blood Flow Restriction Therapy
Not yet recruitingPhase 1
Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.
Achilles Tendon Repairs/Reconstructions, Pilon Fracture of Tibia
Not yet recruiting
Effect Of Games Based Virtual Reality On Promoting Early Functional Recovery After Foot Tendon Repair
Virtual Reality, Achilles Tendon Repairs/Reconstructions
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexor hallucis longus tendon transfer and Gastrocnemius augmented Flexor hallucis longus tendon transfer in people with Achilles Tendon Repairs/reconstructions and Achilles Tendon Rupture, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 4 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 26 Feb 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 Egypt. 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 Moaiadeldin A. Abelmawla (+201028591904, moaied.16285824@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle Society (AOFAS) Score Ankle-Hindfoot Scale (time frame: at 6 months, and 1 year follow up visits). 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?
On the ClinicalTrials.gov record for NCT06847971, which also lists 12 linked publications.
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 26 Feb 2025.