Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession

NCT05179551 | Recruiting

• 1 other identifier: REK244374
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective cohort study that will follow 60 patients treated with Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy for 5 years postoperatively.

Conditions

Achilles Tendinopathy; Chronic Pain

Outcome Measures

Primary Outcomes (5)

• VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

  A PROM validated for patients with achilles tendon disorders

  Baseline

• VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

  A PROM validated for patients with achilles tendon disorders

  3 months

• VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

  A PROM validated for patients with achilles tendon disorders

  1 year

• VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

  A PROM validated for patients with achilles tendon disorders

  2 years

• VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

  A PROM validated for patients with achilles tendon disorders

  5 years

Secondary Outcomes (13)

• Achilles Function Test battery

  Baseline, 3 months, 2 years

• Ankle Dorsiflexion pre and postoperatively

  Baseline, 3 months, 2 years

• MRI findings pre inclusion versus after 2 years.

  Baseline, 2years

• VAS

  Baseline, 3 months, 1 year, 2 years, 5 years

• Eq-5D

  Baseline, 3 months, 1 year, 2 years, 5 years

Study Arms (1)

Proximal Medial Gastrocnemius Recession Surgery

EXPERIMENTAL

Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.

Procedure: Proximal Medial Gastrocnemius Recession

Interventions

Proximal Medial Gastrocnemius Recession PROCEDURE

. A 3-4 cm transverse skin incision is made in the popliteal fossa, the superficial fascia is opened, and the medial gastrocnemius with its tendon (aponeurosis) is located. The tendon is then cut while lifting it with clamps, and care is taken to cut only the white tendon while sparing the underlying muscle. While performing a dorsiflexion movement of the ankle, careful palpation of the muscle is done to ensure that all tendon strands are cut completely. The incision is closed in layers, and only soft dressings applied

Also known as: PMGR

Proximal Medial Gastrocnemius Recession Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years.
• Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
• Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
• Duration of symptoms must be at least 12 months.
• At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.

You may not qualify if:

• 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 to jeopardize 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.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Oslo University Hospital, Orthopedic Department Ullevål

Oslo, 1714, Norway

RECRUITING

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marius Molund, PhD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin O Riiser, MD

CONTACT

+4797146230; riiser.martin@gmail.com

Marius Molund, MD PhD

CONTACT

+4790003099; mariusmolund@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Cohort Study

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: January 5, 2022
• Study Start: December 31, 2021
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)