Achilles TendinopathyNCT06030908
Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.
An observational study of Achilles Tendinopathy and Insertional Achilles Tendinopathy, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
Trial summary
The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy, Insertional Achilles Tendinopathy
- What is being tested?
- Reconstruction of Achilles tendon insertion
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteAustria
- Study dates
- 13 Sep 2022to Oct 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion between 01/2018 and 10/2021.
Who may be able to join
- All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.
Who cannot join
- Lack of informed consent
- Revision surgery
- Patients who had another operation on the same leg during the same procedure or 6 months later
Trial locations and contacts
1 site in 1 country.
Austria1 site
Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie
Linz, 4010
About this study
Official title: Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.
The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.
Read the detailed description
The lifetime risk of Achilles tendon pain is approximately 6%, one-third of whom complain of pain at the bony attachment of the Achilles tendon to the calcaneus.
Primary treatment of these insertional tendinopathies is always nonsurgical with physical therapy, orthotics, shock wave therapy, or various forms of injections. If there is no response to therapy, surgery is warranted after three to six months. In this procedure, the tendon is detached from the bone, the damaged portions of the tendon are removed, bony prominences are rounded, and finally the tendon attachment is reconstructed and fixed with anchors. Various anchor systems are available for this purpose.
The double-row anchor system used by the investigators in recent years allows stable, knotless, two-dimensional refixation of the Achilles tendon to the calcaneus and thus permits rapid rehabilitation. Recent studies show good functional results 33 months after reconstruction of the Achilles tendon attachment with the "Speed Bridge" System. To the best of our knowledge, however, there are no studies to date on sports ability after this operation.
The investigators are therefore conducting a retrospective collection of clinical patient data combined with a planned (prospective) questionnaire survey of patients with insertional Achilles tendon tendinopathy who received surgical treatment with tendon refixation.
- Being tested
- Reconstruction of Achilles tendon insertion
- Keywords
- insertional, Achilles Tendinopathy, surgery, sport
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reconstruction of Achilles tendon insertionProcedure or surgery
knotless double-row anchor fixation of the achilles tendon insertion
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Patients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system. Receives: Procedure: Reconstruction of Achilles tendon insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to sports Rate
in percentage compared to preoperatively
Measured: minimum 12 months from surgery to follow-up
Secondary outcomes (6)
Number of sport units per week, sport disciplines practiced
in absolute numbers
Measured: minimum 12 months from surgery to follow-up
Length of sport units
in minutes
Measured: minimum 12 months from surgery to follow-up
Range of motion after surgery
in degrees
Measured: minimum 12 months from surgery to follow-up
Subjective change of instability after surgery
Visual analog scale; 0-10; 0 means no instability, 10 means worst instability
Measured: minimum 12 months from surgery to follow-up
Change of pain after surgery
Visual analog scale; 0-10; 0 means no pain, 10 means worst pain
Measured: minimum 12 months from surgery to follow-up
Satisfaction with result
Visual analog scale; 0-10; 0 means not satisfied, 10 means maximum satisfaction
Measured: minimum 12 months from surgery to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start13 Sep 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies 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
- Case only
- Time perspective
- Other
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krankenhaus Barmherzige Schwestern Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030908
- Sponsor's protocol ID
- AST_2023
- Status last verified
- Nov 2023
- First submitted
- 28 Aug 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.
- ClinicalTrials.gov ID
- NCT06030908
- Acronym / sponsor ID
- AST_2023
- Keywords
- insertional, Achilles Tendinopathy, surgery, sport
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Krankenhaus Barmherzige Schwestern LinzUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 11 Sep 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 this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.
Detailed description
The lifetime risk of Achilles tendon pain is approximately 6%, one-third of whom complain of pain at the bony attachment of the Achilles tendon to the calcaneus.
Primary treatment of these insertional tendinopathies is always nonsurgical with physical therapy, orthotics, shock wave therapy, or various forms of injections. If there is no response to therapy, surgery is warranted after three to six months. In this procedure, the tendon is detached from the bone, the damaged portions of the tendon are removed, bony prominences are rounded, and finally the tendon attachment is reconstructed and fixed with anchors. Various anchor systems are available for this purpose.
The double-row anchor system used by the investigators in recent years allows stable, knotless, two-dimensional refixation of the Achilles tendon to the calcaneus and thus permits rapid rehabilitation. Recent studies show good functional results 33 months after reconstruction of the Achilles tendon attachment with the "Speed Bridge" System. To the best of our knowledge, however, there are no studies to date on sports ability after this operation.
The investigators are therefore conducting a retrospective collection of clinical patient data combined with a planned (prospective) questionnaire survey of patients with insertional Achilles tendon tendinopathy who received surgical treatment with tendon refixation.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Procedure: Reconstruction of Achilles tendon insertionPatients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion between 01/2018 and 10/2021.
Key inclusion criteria (1 listed)
- All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.
Key exclusion criteria (3 listed)
- Lack of informed consent
- Revision surgery
- Patients who had another operation on the same leg during the same procedure or 6 months later
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 |
|---|---|---|
| Reconstruction of Achilles tendon insertionknotless double-row anchor fixation of the achilles tendon insertion | Procedure or surgery | Study Population |
Primary outcome
Return to sports Rate
Time frame: minimum 12 months from surgery to follow-up
in percentage compared to preoperatively
6 secondary outcomes
Number of sport units per week, sport disciplines practiced
Time frame: minimum 12 months from surgery to follow-up
Length of sport units
Time frame: minimum 12 months from surgery to follow-up
Range of motion after surgery
Time frame: minimum 12 months from surgery to follow-up
Subjective change of instability after surgery
Time frame: minimum 12 months from surgery to follow-up
Change of pain after surgery
Time frame: minimum 12 months from surgery to follow-up
Satisfaction with result
Time frame: minimum 12 months from surgery to follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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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.
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 Tendinopathy and Insertional Achilles Tendinopathy, run by Krankenhaus Barmherzige Schwestern Linz at 1 site in Austria.
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 29 Nov 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 Austria. 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?
Return to sports Rate (time frame: minimum 12 months from surgery to follow-up). 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 29 Nov 2023.