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Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

Primary Purpose

Chronic Plantar Fasciitis

Status

Recruiting

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Proximal Medial Gastrocnemius Recession

About this trial

This is an interventional treatment trial for Chronic Plantar Fasciitis focused on measuring proximal medial gastrocnemius recession, MOxFQ, VAS, EQ5D, MRI, Regression analysis, Ankle movement, Adverse events

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Østfold Hospital TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Proximal Medial Gastrocnemius Recession Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

Manchester Oxford Foot Questionnaire (MOxFQ)

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Manchester Oxford Foot Questionnaire (MOxFQ)

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Manchester Oxford Foot Questionnaire (MOxFQ)

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Manchester Oxford Foot Questionnaire (MOxFQ)

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Manchester Oxford Foot Questionnaire (MOxFQ)

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Secondary Outcome Measures

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.

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

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.

Adverse events

infection, nerve injury, thrombosis.

Ankle movement

Ankle dorsiflexion measured in degrees, through a validated gonimeter

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.

Full Information

NCT ID

NCT05162144

First Posted

December 1, 2021

Last Updated

March 20, 2023

Sponsor

Ostfold Hospital Trust

1. Study Identification

Unique Protocol Identification Number

NCT05162144

Brief Title

Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2021 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ostfold Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Plantar Fasciitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective Cohort Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Proximal Medial Gastrocnemius Recession Surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Proximal Medial Gastrocnemius Recession

Other Intervention Name(s)

PMGR

Intervention Description

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.

Primary Outcome Measure Information:

Title

Manchester Oxford Foot Questionnaire (MOxFQ)

Description

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Time Frame

Baseline

Title

Manchester Oxford Foot Questionnaire (MOxFQ)

Description

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Time Frame

6 weeks postoperatively

Title

Manchester Oxford Foot Questionnaire (MOxFQ)

Description

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Time Frame

12 weeks postoperatively

Title

Manchester Oxford Foot Questionnaire (MOxFQ)

Description

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Time Frame

1 year postoperatively

Title

Manchester Oxford Foot Questionnaire (MOxFQ)

Description

Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle

Time Frame

2 years postoperatively

Secondary Outcome Measure Information:

Title

VAS (visual analogue scale)

Description

Visual analogue scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable.

Time Frame

Baseline, 12 weeks, 1 year, 2 years

Title

EQ5D (EuroQol questionnaire )

Description

Time Frame

Baseline, 12 weeks, 1 year, 2 years

Title

MRI (magnetic resonancd imaging) findings

Description

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.

Time Frame

Baseline, 2years

Title

Adverse events

Description

infection, nerve injury, thrombosis.

Time Frame

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

Title

Ankle movement

Description

Ankle dorsiflexion measured in degrees, through a validated gonimeter

Time Frame

Baseline, 12 weeks, 2 years

Title

Gait analysis

Description

Time Frame

Baseline, 3 months

Other Pre-specified Outcome Measures:

Title

Baseline Patient related factors

Description

The baseline assessment of outcomes and baseline data will be performed no less than two-four weeks before intervention. Baseline data includes Age, sex, BMI, smoking, medication, diabetes, rheumatologic disease, employment, type of employment, education level, duration of symptoms, previous treatments, activity level, clinical varus/valgus deformity, use of insoles, previous surgeries in affected foot/ankle for other conditions, clinical hallux valgus deformity, symptomatic hallux valgus deformity, taylors bunion, stable/unstable ankle joint, dominant foot, MRI findings (2), X-ray finding (1): Heel spur. Total number of variables: 26 These data will later be used in regression analysis.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marius Molund, MD PhD

Phone

+4790093988

mariusmolund@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Martin O Riiser, MD Phd candidate

Phone

+4797146230

riiser.martin@gmail.com

Facility Information:

Facility Name

Østfold Hospital Trust

City

Sarpsborg

ZIP/Postal Code

1714

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marius Molund, MD PhD

Phone

+4790093988

mariusmolund@hotmail.com

First Name & Middle Initial & Last Name & Degree

Martin O Riiser, MD PhD candidate

Phone

+4797146230

riiser.martin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis

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