Outcome After Surgical Reconstruction of the Achilles Tendon Insertion.

Achilles Tendinopathy Clinical Trial

Official title:

Functional Outcomes and Return to Sports After Surgical Treatment of Insertional Achilles Tendinopathy With Tendon Debridement and Anchor Refixation.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06030908
• Other study ID #: AST_2023
• Status: Active, not recruiting
• Start date: September 13, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Krankenhaus Barmherzige Schwestern Linz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendinopathy
• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

Procedure:
• Reconstruction of Achilles tendon insertion
knotless double-row anchor fixation of the achilles tendon insertion

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie	Linz

Sponsors (1)

Lead Sponsor	Collaborator
Krankenhaus Barmherzige Schwestern Linz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to sports Rate	in percentage compared to preoperatively	minimum 12 months from surgery to follow-up
Secondary	Number of sport units per week, sport disciplines practiced	in absolute numbers	minimum 12 months from surgery to follow-up
Secondary	Length of sport units	in minutes	minimum 12 months from surgery to follow-up
Secondary	Range of motion after surgery	in degrees	minimum 12 months from surgery to follow-up
Secondary	Subjective change of instability after surgery	Visual analog scale; 0-10; 0 means no instability, 10 means worst instability	minimum 12 months from surgery to follow-up
Secondary	Change of pain after surgery	Visual analog scale; 0-10; 0 means no pain, 10 means worst pain	minimum 12 months from surgery to follow-up
Secondary	Satisfaction with result	Visual analog scale; 0-10; 0 means not satisfied, 10 means maximum satisfaction	minimum 12 months from surgery to follow-up