Achilles Tendon RuptureNCT06641401
Endoscopic FHL Transfer for Acute Achilles Tendon Rupture
An observational study of Achilles Tendon Rupture and Achilles Tendon Injury, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
This observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR). Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Achilles Tendon Rupture, Achilles Tendon Injury, Achilles Tendon Surgery
- What is being tested?
- Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteGreece
- Study dates
- 5 Mar 2023to 30 Dec 2025
- 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 to 18 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who underwent endoscopic flexor hallucis longus transfer for acute Achilles tendon rupture by a single surgeon in a single hospital
Who may be able to join
- Signed Consent Form
- Acute Achilles Tendon Rupture (<4 weeks)
- Underwent operative treatment with Endoscopic Flexor Hallucis Longus transfer
- More than 24 months postoperative follow-up
- Patients operated after 2015
Who cannot join
- Inability or Unwillingness to cooperate
- Medically unfit for examination
- Age less than 18 or more than 75 years
- Non-operative Management or any other Surgical Management
- Neglected Achilles Tendon Rupture (>4 weeks)
- Bilateral Achilles Tendon Rupture
- Patients operated before 1.1.2015 or after 1.1.2023
- Comorbidities interfering with the secondary outcomes (e.g. Venous insufficiency resulting in lower limb excessive edema interferes with ankle and calf circumference, rheumatoid arthritis and/or previous foot and ankle surgery interferes with active and passive range of motion of the ankle, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case Series of Endoscopic Flexor Hallucis Longus Transfer for Acute Achilles Tendon Rupture.
This observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR).
Read the detailed description
This evaluation will be performed by examining the following parameters:
- Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.
- Complication rate
- Ankle and Calf circumference compared to the contralateral healthy limb.
- Passive and Active range of ankle motion compared to the contralateral healthy limb.
- Hallux flexion force compared to the contralateral healthy limb.
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Injury, Achilles Tendon Surgery, Flexor Hallucis Longus
- Being tested
- Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture
- Keywords
- Achilles tendon, rupture, endoscopic, flexor hallucis longus transfer
- Medical subject headings
- Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon ruptureProcedure or surgery
All patients have already undergone the same operation for the same disease. All data are to be collected retrospectively
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Flexor Hallucis Longus Transfer Group | 28 Patients with acute Achilles tendon rupture treated with Endoscopic Flexor Hallucis Longus transfer by a single surgeon in a single hospital (General Hospital of Naousa, Greece). All patients followed the same postoperative rehabilitation program. Receives: Procedure: Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)
Measured: At least 24 months postoperatively
Secondary outcomes (4)
Complication rate
Complications will be recorded and categorized: Rerupture, Infection, Nerve injury, Miscellaneous
Measured: At least 24 months postoperatively
Calf Circumference
Calf circumference measured 15 cm distally to the inferior pole of the patella. Contralateral limb calf circumference will also be measured. The Calf Circumference Difference will be calculated and compared between the two groups.
Measured: At least 24 months postoperatively
Ankle Circumference
Ankle circumference measured 8 cm proximally to the lateral malleolus. Contralateral limb ankle circumference will also be measured. The Ankle Circumference Difference will be calculated and compared between the two groups.
Measured: At least 24 months postoperatively
Ankle Range of Motion
Active and Passive Ankle joint Range of Motion will be calculated with an electronic goniometer. Contralateral limb Range of Ankle joint Motion will also be measured. The Range of Motion Difference will be calculated and compared between the two groups.
Measured: At least 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start5 Mar 2023
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Naoussa
- Responsible party
- Principal investigator, Michail Kotsapas, Aristotle University Of Thessaloniki
- Investigators
- Michail Kotsapas, MD, MSc, Principal investigator, General Hospital of Naousa, Department of Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641401
- Sponsor's protocol ID
- 6/14.6.2022
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The records of each patient to be enrolled belong to the General Hospital of Naousa. The records of each patient will be entrusted to the main researcher (M.K.) with the obligation to maintain doctor-patient confidentiality. The final study results will not reveal any sensitive patient data (de-identification). Photos and videos of each patient's examination may be taken after ensuring their written and oral informed consent.
Publications
Abdelatif NMN, Batista JP. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures in Professional Soccer Players. Foot Ankle Int. 2022 Feb;43(2):164-175. doi: 10.1177/10711007211036439. Epub 2021 Sep 24.
PubMed 34558318Batista JP, Abdelatif NMN, Del Vecchio JJ, Diniz P, Pereira H. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures: A Prospective Case Series Report With a Minimum of 18 Months' Follow-Up. J Foot Ankle Surg. 2020 Sep-Oct;59(5):927-937. doi: 10.1053/j.jfas.2019.12.008. Epub 2020 Jun 9.
PubMed 32527698
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series of Endoscopic Flexor Hallucis Longus Transfer for Acute Achilles Tendon Rupture.
- ClinicalTrials.gov ID
- NCT06641401
- Acronym / sponsor ID
- 6/14.6.2022
- Conditions
- Achilles Tendon Rupture, Achilles Tendon Injury, Achilles Tendon Surgery, Flexor Hallucis Longus
- Keywords
- Achilles tendon, rupture, endoscopic, flexor hallucis longus transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- General Hospital of Naoussa
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 15 Oct 2024 (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 observational study aims to evaluate the outcome of endoscopic flexor hallucis longus transfer (FHLt) in patients with acute Achilles tendon rupture (AATR).
Detailed description
This evaluation will be performed by examining the following parameters:
- Patient satisfaction quantified with the Achilles tendon Total Rupture Score (ATRS). This is the primary outcome.
- Complication rate
- Ankle and Calf circumference compared to the contralateral healthy limb.
- Passive and Active range of ankle motion compared to the contralateral healthy limb.
- Hallux flexion force compared to the contralateral healthy limb.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Flexor Hallucis Longus Transfer Group | – | Procedure: Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon rupture28 Patients with acute Achilles tendon rupture treated with Endoscopic Flexor Hallucis Longus transfer by a single surgeon in a single hospital (General Hospital of Naousa, Greece). All patients followed the same postoperative rehabilitation program. |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who underwent endoscopic flexor hallucis longus transfer for acute Achilles tendon rupture by a single surgeon in a single hospital
Key inclusion criteria (5 listed)
- Signed Consent Form
- Acute Achilles Tendon Rupture (<4 weeks)
- Underwent operative treatment with Endoscopic Flexor Hallucis Longus transfer
- More than 24 months postoperative follow-up
- Patients operated after 2015
Key exclusion criteria (8 listed)
- Inability or Unwillingness to cooperate
- Medically unfit for examination
- Age less than 18 or more than 75 years
- Non-operative Management or any other Surgical Management
- Neglected Achilles Tendon Rupture (>4 weeks)
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 |
|---|---|---|
| Endoscopic Flexor Hallucis Longus transfer for Acute Achilles tendon ruptureAll patients have already undergone the same operation for the same disease. All data are to be collected retrospectively | Procedure or surgery | Endoscopic Flexor Hallucis Longus Transfer Group |
Primary outcome
Patient Satisfaction
Time frame: At least 24 months postoperatively
Evaluated and quantified with the Achilles Tendon Total Rupture Score (min = 0 - worst outcome, max = 100 - best outcome)
4 secondary outcomes
Complication rate
Time frame: At least 24 months postoperatively
Calf Circumference
Time frame: At least 24 months postoperatively
Ankle Circumference
Time frame: At least 24 months postoperatively
Ankle Range of Motion
Time frame: At least 24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 34558318Abdelatif NMN, Batista JP. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures in Professional Soccer Players. Foot Ankle Int. 2022 Feb;43(2):164-175. doi: 10.1177/10711007211036439. Epub 2021 Sep 24.
- Results publication: PubMed 32527698Batista JP, Abdelatif NMN, Del Vecchio JJ, Diniz P, Pereira H. Endoscopic Flexor Hallucis Longus Transfer for the Management of Acute Achilles Tendon Ruptures: A Prospective Case Series Report With a Minimum of 18 Months' Follow-Up. J Foot Ankle Surg. 2020 Sep-Oct;59(5):927-937. doi: 10.1053/j.jfas.2019.12.008. Epub 2020 Jun 9.
- Individual participant dataSharing planned: Undecided. The records of each patient to be enrolled belong to the General Hospital of Naousa. The records of each patient will be entrusted to the main researcher (M.K.) with the obligation to maintain doctor-patient confidentiality. The final study results will not reveal any sensitive patient data (de-identification). Photos and videos of each patient's examination may be taken after ensuring their written and oral informed consent.
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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.
Michail Kotsapas, MD, MSc principal investigator
General Hospital of Naousa, Department of Orthopedics
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 and Achilles Tendon Injury, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. 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 Greece. 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?
Results are not available in the source record.
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?
Patient Satisfaction (time frame: At least 24 months postoperatively). 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 NCT06641401, which also lists 2 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 15 Oct 2024.