Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508810219487 Date of Registration: 08/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A comparison between endoscopic and open flexor hallucis longus tendon transfer in patients with chronic Achilles tendon rupture
Official scientific title Endoscopic vs Open Flexor Hallucis Longus Transfer in Chronic Achilles Tendon Rupture: A Prospective Comparative Pilot Study
Brief summary describing the background and objectives of the trial Chronic Achilles tendon rupture is a disabling condition that often results from missed or untreated acute injuries. When primary repair is not feasible due to tendon retraction or degeneration, surgical reconstruction becomes necessary. Flexor hallucis longus (FHL) tendon transfer is a widely accepted option, offering favorable biomechanical and anatomical properties. While the open surgical technique is well established, endoscopic approaches have emerged as a minimally invasive alternative, potentially reducing wound complications and promoting faster recovery. However, evidence comparing the functional outcomes and surgical parameters between these techniques remains limited. This prospective comparative pilot study aims to evaluate the functional outcome, wound complication rate, and operative time between endoscopic and open FHL transfer techniques in patients with chronic Achilles tendon rupture.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) FLEX-Achilles
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 20/01/2024
Actual trial start date 20/01/2024
Anticipated date of last follow up 29/07/2024
Actual Last follow-up date 29/07/2024
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endoscopic tendon transfer 12 month Experimental Arm – Endoscopic Flexor Hallucis Longus (FHL) Transfer Participants in this group undergo minimally invasive endoscopic harvesting and transfer of the flexor hallucis longus tendon for reconstruction of chronic Achilles tendon rupture. The FHL tendon is identified and harvested endoscopically through small incisions using specialized instruments. A tunnel is created in the calcaneus near the Achilles tendon footprint, and the tendon is fixed using a pull-out suture or interference screw. This approach is designed to minimize soft tissue disruption and reduce wound complications while achieving functional restoration. 15
Control Group Open tendon transfer 12 months Control Arm – Open Flexor Hallucis Longus (FHL) Transfer Participants in this group undergo conventional open surgical harvesting and transfer of the flexor hallucis longus tendon for reconstruction of chronic Achilles tendon rupture. Through a standard open posterior approach, the FHL tendon is exposed, harvested, and transferred to a tunnel drilled in the calcaneus. Fixation is achieved using a pull-out suture or interference screw. This is the standard method with proven effectiveness but higher risk of wound complications compared to the endoscopic approach. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults aged 18 to 60 years 2. Diagnosed with chronic Achilles tendon rupture 3. Duration of rupture greater than 6 weeks 4. Tear type: Degenerative or traumatic 5. Tear location: Insertional or intrasubstance 6. Diagnosis confirmed by MRI Open ruptures Acute tear Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/01/2024 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
56 Ramsis Street, Abbasseya, Cairo, Egypt Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Foot and Ankle Ability Measure (FAAM) score Measured at: 6 weeks, 3 months, 6 months, and 12 months post intervention. Measured at: 6 weeks, 3 months, 6 months, and 12 months post intervention.
Secondary Outcome Wound complications (within 30 days postoperative) Operative time (measured intraoperatively) 30.days Wound complications / 0 days Operative time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university Hospitals 38 Abbassia Street, Abbassia, Cairo, Egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
AbdelRahman AbdelSalam Sayed Afifi 56 Ramsis Street Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Faculty of Medicine 56 Ramsis Street Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdelrahman Afifi abdelrahman-abdo2019@outlook.com 00201121139003 Heliopolis
City Postal code Country Position/Affiliation
Cairo 11771 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Awab Elaslaby proawab@med.asu.edu.eg 00201095623576 El matareya
City Postal code Country Position/Affiliation
Cairo Egypt Consultant
Role Name Email Phone Street address
Scientific Enquiries Amr Farouk Amrfarouk@med.asu.edu.eg 00201007090067 New cairo
City Postal code Country Position/Affiliation
Cairo Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) related to the primary and secondary outcomes, including Foot and Ankle Ability Measure (FAAM) scores, operative time, and wound complication rates, will be made available upon reasonable request. Data will be shared following publication of the main study results or within 12 months of study completion, whichever comes first. Access will be granted to qualified researchers for academic and non-commercial use, subject to approval by the principal investigator and Ain Shams University Research Ethics Committee. Informed Consent Form,Study Protocol Within 12 months after study completion or upon publication of the main study results, whichever occurs first. Individual participant data (IPD) will be made available to qualified researchers upon reasonable request. Requests must include a methodologically sound proposal and a data use agreement. Access will be granted for academic, non-commercial purposes only, subject to approval by the principal investigator and Ain Shams University Research Ethics Committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 01/08/2025 Age group from 18 to 60 years Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 01/08/2025 I declared that the outcomes will be postoperative follow up Primary Outcome, Foot and Ankle Ability Measure (FAAM) score Measured at: 6 weeks, 3 months, 6 months, and 12 months, Measured at: 6 weeks, 3 months, 6 months, and 12 months Primary Outcome, Foot and Ankle Ability Measure (FAAM) score Measured at: 6 weeks, 3 months, 6 months, and 12 months post intervention., Measured at: 6 weeks, 3 months, 6 months, and 12 months post intervention.
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 01/08/2025 As I received that the Source Name should be the ACTUAL name of the Principal Investigator / Individual / Institution / Hospital / University of Funding Agency providing the funding Investigator funded, 56 Ramsis Street, Cairo , 11566, Egypt, Self Funded, Self funded, 56 Ramsis Street, Cairo , 11566, Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 06/08/2025 As I received that the Source Name should be the ACTUAL name of the Principal Investigator / Individual / Institution / Hospital / University of Funding Agency providing the funding Self funded, 56 Ramsis Street, Cairo , 11566, Egypt, Self Funded, AbdelRahman AbdelSalam Sayed Afifi, 56 Ramsis Street, Cairo , 11566, Egypt, Other, Individual