Clinical trial NCT05162144: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Plantar Fasciitis
Keywords: proximal medial gastrocnemius recession
MOxFQ
VAS
EQ5D
MRI
Regression analysis
Ankle movement
Adverse events
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Cohort Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Manchester Oxford Foot Questionnaire (MOxFQ)
timeFrame: Baseline
measure: Manchester Oxford Foot Questionnaire (MOxFQ)
timeFrame: 6 weeks postoperatively
measure: Manchester Oxford Foot Questionnaire (MOxFQ)
timeFrame: 12 weeks postoperatively
measure: Manchester Oxford Foot Questionnaire (MOxFQ)
timeFrame: 1 year postoperatively
measure: Manchester Oxford Foot Questionnaire (MOxFQ)
timeFrame: 2 years postoperatively
Secondary outcomes:
measure: VAS (visual analogue scale)
timeFrame: Baseline, 12 weeks, 1 year, 2 years
measure: EQ5D (EuroQol questionnaire )
timeFrame: Baseline, 12 weeks, 1 year, 2 years
measure: MRI (magnetic resonancd imaging) findings
timeFrame: Baseline, 2years
measure: Adverse events
timeFrame: Baseline, 6 weeks, 12 weeks, 1 year, 2 years
measure: Ankle movement
timeFrame: Baseline, 12 weeks, 2 years
measure: Gait analysis - Maximal ankle dorsiflexion during stance (degrees)
timeFrame: Baseline, 3 months
measure: Gait analysis (Length of stride. Centimeters)
timeFrame: Baseline, 3 months
measure: Gait analysis Ankle power
timeFrame: Baseline, 3 months
measure: Gait analysis Cadence (steps/minute)
timeFrame: Baseline, 3 months
measure: Gait analysis Maximal external rotation of ankle during stance (degrees)
timeFrame: Baseline, 3 months
measure: Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)
timeFrame: Baseline, 3 months
measure: Assessment of treatment success -pain
timeFrame: at 2 years
measure: Assessment of treatment success - physical activity
timeFrame: at 2 years
measure: Assessment of treatment success - daily living
timeFrame: at 2 years
measure: Assessment of treatment success - other treatments
timeFrame: at 2 years
measure: Assessment of treatment success - patient acceptable symptom state
timeFrame: at 2 years
measure: Assessment of treatment success
timeFrame: at 2 years
Other outcomes:
measure: Baseline Patient related factors
timeFrame: Baseline
Locations:
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
Study officials:
References: