Clinical trial NCT06030908: Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.
Official title: Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Achilles Tendinopathy
Insertional Achilles Tendinopathy
Keywords: insertional
Achilles Tendinopathy
surgery
sport
Lead sponsor: Krankenhaus Barmherzige Schwestern Linz
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion between 01/2018 and 10/2021.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.

Exclusion Criteria:

* Lack of informed consent
* Revision surgery
* Patients who had another operation on the same leg during the same procedure or 6 months later

Primary outcomes:
measure: Return to sports Rate
timeFrame: minimum 12 months from surgery to follow-up
Secondary outcomes:
measure: Number of sport units per week, sport disciplines practiced
timeFrame: minimum 12 months from surgery to follow-up
measure: Length of sport units
timeFrame: minimum 12 months from surgery to follow-up
measure: Range of motion after surgery
timeFrame: minimum 12 months from surgery to follow-up
measure: Subjective change of instability after surgery
timeFrame: minimum 12 months from surgery to follow-up
measure: Change of pain after surgery
timeFrame: minimum 12 months from surgery to follow-up
measure: Satisfaction with result
timeFrame: minimum 12 months from surgery to follow-up
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie
Study officials:
References: