Surgery for chronic Achilles tendon pain

Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy; A Multicenter, Prospective Cohort Study.

This study is testing if surgery can help people with chronic Achilles tendon pain who haven't improved with exercise by following their recovery over five years.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ostfold Hospital Trust (Academic / other)
• Locations: 2 sites (Oslo and 1 other locations)
• Trial ID: NCT05179551 on ClinicalTrials.gov

What this trial studies

This prospective cohort study will follow 60 patients suffering from Chronic Mid-Portion Achilles Tendinopathy who have not responded to eccentric training. Participants will undergo Proximal Medial Gastrocnemius Recession surgery and will be monitored for 5 years postoperatively. The study aims to assess the effectiveness of this surgical intervention through patient-reported outcome measures, muscle function tests, and MRI scans. The goal is to provide new insights into a treatment approach that has shown promise in retrospective studies but lacks prospective data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with chronic mid-portion Achilles tendinopathy that has persisted for at least 12 months despite physical therapy.

Not a fit: Patients with a history of complete Achilles tendon rupture or other combined pathologies in the Achilles tendon may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new surgical option for patients with chronic Achilles tendon pain who have not benefited from conservative treatments.

How similar studies have performed: While retrospective studies suggest that Proximal Medial Gastrocnemius Recession may be effective, this approach has not been extensively tested in prospective studies.

Eligibility criteria

Inclusion criteria:

1. Age 18-75 years.
2. Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
3. Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
4. Duration of symptoms must be at least 12 months.
5. Isolated gastrocnemius tightness must be verified with the Silfverskiölds test before inclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee.
6. At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.

Exclusion criteria:

1. Previous history of complete Achilles tendon rupture.
2. Other combined pathologies in the Achilles tendon of calf (Sequela from trauma, infections, cancer etc.).
3. Insertional Achilles tendinopathy.
4. Previously undergone surgery in affected tendon.
5. Patients with severe talocrural pathology or serious malalignment of foot and ankle.
6. Severely reduced peripheral circulation.
7. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
8. Patients with a contraindication/non-compliance for MRI examination.
9. History of allergic reaction/anaphylactic reaction to local anesthetics.
10. Not able to read and/or speak a Scandinavian language or English adequately.
11. Other serious comorbidity that makes surgery unadvisable.

Where this trial is running

Oslo and 1 other locations

• Oslo University Hospital, Orthopedic Department Ullevål — Oslo, Norway (Recruiting)
• Østfold Hospital Trust — Sarpsborg, Østfold, Norway (Recruiting)

Study contacts

• Principal investigator: Marius Molund, PhD — Ostfold Hospital Trust
• Study coordinator: Martin O Riiser, MD

Conditions Achilles Tendinopathy; Chronic Pain