Achilles Tendon RuptureNCT02996253
Endoscopic Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture
An observational study of Achilles Tendon Rupture, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- FHL transfer
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2015to Feb 2024
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With chronic Achilles Tendon Rupture
Who may be able to join
- Chronic Achilles Tendon Rupture
Who cannot join
- Pregnancy
- BMI<18.5 or >39.9
- Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study
The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.
Read the detailed description
The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery.
Prospective study for evaluation of the surgical procedure.
- Conditions
- Achilles Tendon Rupture
- Being tested
- FHL transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FHL transferProcedure or surgery
endoscopic transfer og flexor hallucis longus
What is being measured
The primary outcome is the main question the study is designed to answer.
The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score
Measured: one year after FHL transfer
Secondary outcomes (7)
Visual Analogue Scale for Pain (VAS pain) score
patient reported outcome
Measured: 3, 6 and 12 months after FHL transfer
patient reported function score (PRFS)
patient reported Activity related disability
Measured: 6, 12 months
Magnetic resonance imagine (MRI)
FHL hypertrophy
Measured: one year post surgery
functional test battery
jump- and strength tests
Measured: 12 months
local wound conditions
wound infection
Measured: within 12 weeks
AOFAS hindfoot
Measured: 3,6,12 months
VISA-A
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2022
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Fredrikstad
- Responsible party
- Principal investigator, Elisabeth Ellingsen Husebye, Oslo University Hospital
- Investigators
- Elisabeth E Husebye, MD, PhD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996253
- Sponsor's protocol ID
- 2015/16389
- Other IDs
- 2015
- Status last verified
- Mar 2023
- First submitted
- 7 Dec 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Assisted Transfer of Flexor Hallucis Longus Tendon for Chronic Achilles Tendon Rupture. A Prospective Multi Center Cohort Study
- ClinicalTrials.gov ID
- NCT02996253
- Acronym / sponsor ID
- 2015/16389
- Conditions
- Achilles Tendon Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Central Hospital, Fredrikstad
- Study start
- Dec 2015
- Primary completion
- Feb 2022 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 19 Dec 2016 (estimated)
- 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.
The transfer of Flexor Hallucis Longus (FHL) in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome, but an extensive surgical field at a vulnerable location may lead to increased risk for soft tissue problems. The arthroscopic FHL transfer may reduce the risk for soft tissue problems. Functional outcome parameters are investigated, wound/soft tissue complications registered.
Detailed description
The transfer of FHL in the management of chronic Achilles tendon ruptures has demonstrated good functional outcome with American Orthopaedic Foot ane Ankle Society (AOFAS) hindfoot scores at 80-89. The extensive surgical field by either a two-incision approach or a single longitudinal posterior approach to the Achilles tendon may lead to an increased risk for soft tissue problems, both infections and wound healing problems. The endoscopic FHL transfer may reduce the risk for soft tissue problems while retaining a good functional outcome. Several functional outcome measures and scores are evaluated a year after surgery.
Prospective study for evaluation of the surgical procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With chronic Achilles Tendon Rupture
Key inclusion criteria (1 listed)
- Chronic Achilles Tendon Rupture
Key exclusion criteria (3 listed)
- Pregnancy
- BMI<18.5 or >39.9
- Insufficient Norwegian Language proficiency lack of communication skills local skin conditions at site for planned surgery
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 |
|---|---|---|
| FHL transferendoscopic transfer og flexor hallucis longus | Procedure or surgery | – |
Primary outcome
The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score
Time frame: one year after FHL transfer
7 secondary outcomes
Visual Analogue Scale for Pain (VAS pain) score
Time frame: 3, 6 and 12 months after FHL transfer
patient reported function score (PRFS)
Time frame: 6, 12 months
Magnetic resonance imagine (MRI)
Time frame: one year post surgery
functional test battery
Time frame: 12 months
local wound conditions
Time frame: within 12 weeks
AOFAS hindfoot
Time frame: 3,6,12 months
VISA-A
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Elisabeth E Husebye, MD, PhD study chair
Oslo University Hospital
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, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 3 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 22 Mar 2023. 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 Norway. 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?
The Victorian Institute of Sports Assessment- Achilles Questionnaire (VISA-A) outcome score (time frame: one year after FHL transfer). 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 22 Mar 2023.