Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

NCT ID: NCT05162144

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2026-03-15

Brief Summary

This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.

A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,

Detailed Description

Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.

Conditions

Chronic Plantar Fasciitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Proximal Medial Gastrocnemius Recession Surgery

All patients included in the Cohort Study will recieve this PMGR-surgery

Group Type: EXPERIMENTAL

Proximal Medial Gastrocnemius Recession

Intervention Type: PROCEDURE

Patients will be operated with PMGR as described by Barouk. No additional procedures will be performed. The surgery will be performed with the patients in a prone position under local anaesthetics. 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. Patients will be instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients will be allowed to use crutches during the first 2 weeks after surgery. Sutures are removed 2-3 weeks after surgery.

Interventions

Proximal Medial Gastrocnemius Recession

Patients will be operated with PMGR as described by Barouk. No additional procedures will be performed. The surgery will be performed with the patients in a prone position under local anaesthetics. 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. Patients will be instructed to continue the stretching exercises and fully weight-bear from the first postoperative day. If needed, the patients will be allowed to use crutches during the first 2 weeks after surgery. Sutures are removed 2-3 weeks after surgery.

Intervention Type: PROCEDURE

Other Intervention Names

PMGR

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years.

2. Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon.

3. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37)

4. Duration of symptoms must be at least 12 months.

5. An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion.

6. Conventional Physical Therapy must have been tried at least three months without positive effects on symptoms from affected foot.

Exclusion Criteria

1. Previously undergone surgery for plantar fasciitis.

2. Patients with severe talocrural pathology or serious malalignment of foot and ankle

3. Severely reduced peripheral circulation or chronic ulcerations of the foot

4. History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.

5. Patients with a contraindication/non-compliance for MRI examination.

6. Unable to walk without aid.

7. Not able to read and/or speak a Scandinavian language or English adequately.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Østfold Hospital Trust

Sarpsborg, , Norway

Countries

Norway

Other Identifiers

REK317597

Identifier Type: -

Identifier Source: org_study_id