Last updated: March 6, 2024
Sponsor: Ostfold Hospital Trust
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pain
Sprains
Tendon Injuries
Treatment
Proximal Medial Gastrocnemius Recession
Clinical Study ID
NCT05179551
REK244374
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria:
- Age 18-75 years.
- Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must includemid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
- Verified diagnosis with MRI findings representing pathologic processes of tendondegeneration and repair (13). MRI no older than 12 months.
- Duration of symptoms must be at least 12 months.
- Isolated gastrocnemius tightness must be verified with the Silfverskiölds test beforeinclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion isrestricted to 5 degrees or less with the knee extended, and there is an increase ofankle dorsiflexion of at least 10 degrees when flexing the knee.
- At least three months of conventional physical therapy with eccentric training musthave been tried without providing relief of symptoms.
Exclusion
Exclusion criteria:
- Previous history of complete Achilles tendon rupture.
- Other combined pathologies in the Achilles tendon of calf (Sequela from trauma,infections, cancer etc.).
- Insertional Achilles tendinopathy.
- Previously undergone surgery in affected tendon.
- Patients with severe talocrural pathology or serious malalignment of foot and ankle.
- Severely reduced peripheral circulation.
- History of alcoholism, drug abuse, psychological or other emotional problems likely tojeopardize informed consent.
- Patients with a contraindication/non-compliance for MRI examination.
- History of allergic reaction/anaphylactic reaction to local anesthetics.
- Not able to read and/or speak a Scandinavian language or English adequately.
- Other serious comorbidity that makes surgery unadvisable.
Study Design
Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Proximal Medial Gastrocnemius Recession
Phase:
Study Start date:
December 31, 2021
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
Østfold Hospital Trust
Sarpsborg, Østfold 1714
NorwayActive - Recruiting
Oslo University Hospital, Orthopedic Department Ullevål
Oslo, 1714
NorwayActive - Recruiting
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