Achilles Tendon RuptureATRBFHNCT05717270
Two-layer Suturing of Achilles Tendon Ruptures
An observational study of Achilles Tendon Rupture, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Achilles Tendon Rupture
- What is being tested?
- Two-layered suture repair
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteDenmark
- Study dates
- 23 May 2023to 1 Feb 2026
- How long will I take part?
- 12 Months
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with diagnosed acute Achilles tendon rupture
Who may be able to join
- Diagnosed with a traumatic, complete mid-substance Achilles tendon rupture
- Manages transportation to/from the hospital on their own
- Presented within 14 days from injury
- Adult (18 to 60 years)
- Understands Danish
Who cannot join
- Other injuries affecting their lower limb functions
- Prior Achilles contralateral tendon rupture
- Contraindications for MRI
- Re-rupture
- Smoking
- Systemic diseases influencing tendon healing
Show all 9Show fewer
- Anticoagulation treatment
- Inability to follow rehabilitation or complete follow-ups
- Immunosuppressive treatment including systemic corticosteroid treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study
The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493).
The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial
Read the detailed description
This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.
- Conditions
- Achilles Tendon Rupture
- Being tested
- Two-layered suture repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-layered suture repairProcedure or surgery
The ruptured Achilles tendon will be sutured in two-layer.
| Study group | Role | What they receive |
|---|---|---|
| Prospective group | Acute Achilles tendon Rupture undergoing surgical repair. Receives: Procedure: Two-layered suture repair | |
| comparison group | Patients group from a previous trial (NCT04263493). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon length
The distance between the distal muscle fibers of the Soleus muscle and the posterior most superior part of the calcaneus.
Measured: One week after surgery.
Secondary outcomes (8)
Tendon length Soleus
The distance (mm) between the distal muscle fibers of the gastrocnemius muscle and the posterior most superior part of the calcaneus.
Measured: One week after surgery.
Tendon length Triceps Surae
The soleus and gastrocnemius tendon length (mm).
Measured: 6 months.
Plantar flexion function
Heel-rise test
Measured: 6 and 12 months.
Patient perception
Achilles Tendon Total Rupture Score (ATRS). The ATRS consist of 10 items, with a total score range from 0 to 100, and a low score indicate more limitations in physical activity and worse symptoms.
Measured: 12 months
Vascularisation
Doppler flow (area in mm2)
Measured: 6 months.
Muscle architecture fascicle length
Gastrocnemius and soleus muscle fascicle length (mm).
Measured: 6 months.
Muscle architecture pennation angle
Gastrocnemius and soleus muscle pennation angle (°).
Measured: 6 months.
Muscle cross sectional area
Gastrocnemius and soleus tendon and lower limb muscle cross-sectional area (mm2).
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start23 May 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2026 (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.
- 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
- Other
- Enrolment
- 23 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Sofie Agergaard, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717270
- Sponsor's protocol ID
- ATR_sutur_BFH
- Acronym
- ATRBFH
- Status last verified
- Sep 2024
- First submitted
- 26 Jan 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study
- ClinicalTrials.gov ID
- NCT05717270
- Acronym / sponsor ID
- ATRBFH / ATR_sutur_BFH
- Conditions
- Achilles Tendon Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 8 Feb 2023 (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.
The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative. Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493).
The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial
Detailed description
This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group | – | Procedure: Two-layered suture repairAcute Achilles tendon Rupture undergoing surgical repair. |
| comparison group | – | –Patients group from a previous trial (NCT04263493). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with diagnosed acute Achilles tendon rupture
Key inclusion criteria (5 listed)
- Diagnosed with a traumatic, complete mid-substance Achilles tendon rupture
- Manages transportation to/from the hospital on their own
- Presented within 14 days from injury
- Adult (18 to 60 years)
- Understands Danish
Key exclusion criteria (9 listed)
- Other injuries affecting their lower limb functions
- Prior Achilles contralateral tendon rupture
- Contraindications for MRI
- Re-rupture
- Smoking
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 |
|---|---|---|
| Two-layered suture repairThe ruptured Achilles tendon will be sutured in two-layer. | Procedure or surgery | Prospective group |
Primary outcome
Tendon length
Time frame: One week after surgery.
The distance between the distal muscle fibers of the Soleus muscle and the posterior most superior part of the calcaneus.
8 secondary outcomes
Tendon length Soleus
Time frame: One week after surgery.
Tendon length Triceps Surae
Time frame: 6 months.
Plantar flexion function
Time frame: 6 and 12 months.
Patient perception
Time frame: 12 months
Vascularisation
Time frame: 6 months.
Muscle architecture fascicle length
Time frame: 6 months.
Muscle architecture pennation angle
Time frame: 6 months.
Muscle cross sectional area
Time frame: 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Achilles Tendon Rupture
Recruiting
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture
Achilles Tendon Rupture
Enrolling by invitationObservational study
Achilles Non-SNIS REGENETEN
Complete Mid-portion Achilles Rupture
RecruitingObservational study
Achilles Tendon Rupture Patient Outcomes at 12 Months
Achilles Tendon Rupture
Recruiting
Effect of BFR Rehab After Achilles Tendon Rupture
Achilles Tendon Rupture
Active, not recruiting
Eendoscopic Versus Open Flexor Hallucis Longus Transfer in Managing Various Tendon Achilles Disorders
Tendon Tear, Tendinopathy
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?
An observational study of Achilles Tendon Rupture, run by Bispebjerg Hospital at 1 site in Denmark.
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 9 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 27 Sep 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 Denmark. 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?
Tendon length (time frame: One week after surgery.). 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 27 Sep 2024.