- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162144
Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis
Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis - a Prospective Kohort Study
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,
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marius Molund, MD PhD
- Phone Number: +4790093988
- Email: mariusmolund@hotmail.com
Study Contact Backup
- Name: Martin O Riiser, MD PhD candidate
- Phone Number: +4797146230
- Email: riiser.martin@gmail.com
Study Locations
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Sarpsborg, Norway, 1714
- Østfold Hospital Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Proximal Medial Gastrocnemius Recession Surgery
All patients included in the Cohort Study will recieve this PMGR-surgery
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manchester Oxford Foot Questionnaire (MOxFQ)
Time Frame: Baseline
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Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
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Baseline
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Manchester Oxford Foot Questionnaire (MOxFQ)
Time Frame: 6 weeks postoperatively
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Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
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6 weeks postoperatively
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Manchester Oxford Foot Questionnaire (MOxFQ)
Time Frame: 12 weeks postoperatively
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Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
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12 weeks postoperatively
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Manchester Oxford Foot Questionnaire (MOxFQ)
Time Frame: 1 year postoperatively
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Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
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1 year postoperatively
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Manchester Oxford Foot Questionnaire (MOxFQ)
Time Frame: 2 years postoperatively
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Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
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2 years postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS (visual analogue scale)
Time Frame: Baseline, 12 weeks, 1 year, 2 years
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Visual analogue scale for pain during use of affected leg in the last 24 hours.
0 is no pain.
10 is worst pain imaginable.
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Baseline, 12 weeks, 1 year, 2 years
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EQ5D (EuroQol questionnaire )
Time Frame: Baseline, 12 weeks, 1 year, 2 years
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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
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Baseline, 12 weeks, 1 year, 2 years
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MRI (magnetic resonancd imaging) findings
Time Frame: Baseline, 2years
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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.
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Baseline, 2years
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Adverse events
Time Frame: Baseline, 6 weeks, 12 weeks, 1 year, 2 years
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infection, nerve injury, thrombosis.
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Baseline, 6 weeks, 12 weeks, 1 year, 2 years
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Ankle movement
Time Frame: Baseline, 12 weeks, 2 years
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Ankle dorsiflexion measured in degrees, through a validated gonimeter
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Baseline, 12 weeks, 2 years
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Gait analysis - Maximal ankle dorsiflexion during stance (degrees)
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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. - Maximal ankle dorsiflexion during stance (degrees) |
Baseline, 3 months
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Gait analysis (Length of stride. Centimeters)
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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.
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Baseline, 3 months
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Gait analysis Ankle power
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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.
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Baseline, 3 months
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Gait analysis Cadence (steps/minute)
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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.
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Baseline, 3 months
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Gait analysis Maximal external rotation of ankle during stance (degrees)
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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.
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Baseline, 3 months
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Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)
Time Frame: Baseline, 3 months
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A sub-group of patients (n= 30) 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.
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Baseline, 3 months
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Assessment of treatment success -pain
Time Frame: at 2 years
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Likert question: I have pain in the heel pain in the leg that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
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at 2 years
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Assessment of treatment success - physical activity
Time Frame: at 2 years
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Likert question:Heel pain prevents me from performing physical acitvity Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
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at 2 years
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Assessment of treatment success - daily living
Time Frame: at 2 years
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Likert question:Heel pain prevents me from performing activities of daily living Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
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at 2 years
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Assessment of treatment success - other treatments
Time Frame: at 2 years
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Likert question:I have pain and/or discomfort in the calf that was operated two years ago Answers. 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
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at 2 years
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Assessment of treatment success - patient acceptable symptom state
Time Frame: at 2 years
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I have received other treatments for plantar fasciitis since surgery was performed two years ago YES/NO
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at 2 years
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Assessment of treatment success
Time Frame: at 2 years
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If you were to continue having the same level of symptoms in the next few months, would you consider that acceptable. YES/NO |
at 2 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Patient related factors
Time Frame: Baseline
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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. |
Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK317597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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