Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

NCT05162144 | Active Not Recruiting

• 1 other identifier: REK317597
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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,

Conditions

Chronic Plantar Fasciitis

Keywords

proximal medial gastrocnemius recession; MOxFQ; VAS; EQ5D; MRI; Regression analysis; Ankle movement; Adverse events

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (17)

• VAS (visual analogue scale)

  Baseline, 12 weeks, 1 year, 2 years

• EQ5D (EuroQol questionnaire )

  Baseline, 12 weeks, 1 year, 2 years

• MRI (magnetic resonancd imaging) findings

  Baseline, 2years

• Adverse events

  Baseline, 6 weeks, 12 weeks, 1 year, 2 years

• Ankle movement

  Baseline, 12 weeks, 2 years

Other Outcomes (1)

• Baseline Patient related factors

  Baseline

Study Arms (1)

Proximal Medial Gastrocnemius Recession Surgery

EXPERIMENTAL

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

Procedure: Proximal Medial Gastrocnemius Recession

Interventions

Proximal Medial Gastrocnemius Recession 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.

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Østfold Hospital Trust

Sarpsborg, 1714, Norway

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

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: December 1, 2021
• First Posted: December 17, 2021
• Study Start: December 15, 2021
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)