Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis - a Prospective Kohort Study

Conditions
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Chronic Plantar Fasciitis

Intervention / Treatment
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* Procedure: Proximal Medial Gastrocnemius Recession


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18-75 years. Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon. Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37) Duration of symptoms must be at least 12 months. An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion. Conventional Physical Therapy must have been tried at least three months without positive effects on symptoms from affected foot. Exclusion criteria: Previously undergone surgery for plantar fasciitis. Patients with severe talocrural pathology or serious malalignment of foot and ankle Severely reduced peripheral circulation or chronic ulcerations of the foot History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent. Patients with a contraindication/non-compliance for MRI examination. Unable to walk without aid. Not able to read and/or speak a Scandinavian language or English adequately.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Cohort Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proximal Medial Gastrocnemius Recession Surgery<br>All patients included in the Cohort Study will recieve this PMGR-surgery | Procedure: Proximal Medial Gastrocnemius Recession<br>* 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.<br>* Other names: PMGR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manchester Oxford Foot Questionnaire (MOxFQ) | Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle | Baseline | 
| Manchester Oxford Foot Questionnaire (MOxFQ) | Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle | 6 weeks postoperatively | 
| Manchester Oxford Foot Questionnaire (MOxFQ) | Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle | 12 weeks postoperatively | 
| Manchester Oxford Foot Questionnaire (MOxFQ) | Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle | 1 year postoperatively | 
| Manchester Oxford Foot Questionnaire (MOxFQ) | Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle | 2 years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visual analogue scale) | Visual analogue scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable. | Baseline, 12 weeks, 1 year, 2 years | 
| EQ5D (EuroQol questionnaire ) | EQ-5D is a validated generic health-related quality-of-life instrument. It consists of two parts: EQ-5D descriptive part and EQ-5D visual analogue scale. The descriptive part includes five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with three possible answers (no problems, some problems, and major problems). EQ5D VAS is a visual analogue scale of self-related overall health, ranging from 0 (worst imaginable health state) to 100 (best imaginable health state | Baseline, 12 weeks, 1 year, 2 years | 
| MRI (magnetic resonancd imaging) findings | Thickness of plantar fascia at insertion, pathological signals in the fascia yes/no more, less or same as before, presence of oedema in the calcaneal bone yes/no. | Baseline, 2years | 
| Adverse events | infection, nerve injury, thrombosis. | Baseline, 6 weeks, 12 weeks, 1 year, 2 years | 
| Ankle movement | Ankle dorsiflexion measured in degrees, through a validated gonimeter | Baseline, 12 weeks, 2 years | 
| Gait analysis | A sub-group of patients (n= 20) will be offered to be tested in a walking lab, comparing their ankle dorsiflexion during stance pre-and postoperatively. Due to a limited access to this facility, not all patients will be able to perform this test. | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal medial gastrocnemius recession, MOxFQ, VAS, EQ5D, MRI, Regression analysis, Ankle movement, Adverse events