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,
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Østfold Hospital Trust
Sarpsborg, Norway
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Time frame: Baseline
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Time frame: 6 weeks postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Time frame: 12 weeks postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Time frame: 1 year postoperatively
Manchester Oxford Foot Questionnaire (MOxFQ)
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
Time frame: 2 years postoperatively
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.
Time frame: 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
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Time frame: 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.
Time frame: Baseline, 2years
Adverse events
infection, nerve injury, thrombosis.
Time frame: Baseline, 6 weeks, 12 weeks, 1 year, 2 years
Ankle movement
Ankle dorsiflexion measured in degrees, through a validated gonimeter
Time frame: Baseline, 12 weeks, 2 years
Gait analysis - Maximal ankle dorsiflexion during stance (degrees)
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)
Time frame: Baseline, 3 months
Gait analysis (Length of stride. Centimeters)
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.
Time frame: Baseline, 3 months
Gait analysis Ankle power
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.
Time frame: Baseline, 3 months
Gait analysis Cadence (steps/minute)
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.
Time frame: Baseline, 3 months
Gait analysis Maximal external rotation of ankle during stance (degrees)
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) * Length of stride. Centimeters * Cadence (steps/minute) * Ankle power * Maximal external rotation of ankle during stance (degrees) * Knee extension while maximal dorsiflexion of ankle during stance (degrees)
Time frame: Baseline, 3 months
Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)
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.
Time frame: Baseline, 3 months
Assessment of treatment success -pain
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
Time frame: at 2 years
Assessment of treatment success - physical activity
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
Time frame: at 2 years
Assessment of treatment success - daily living
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
Time frame: at 2 years
Assessment of treatment success - other treatments
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
Time frame: at 2 years
Assessment of treatment success - patient acceptable symptom state
I have received other treatments for plantar fasciitis since surgery was performed two years ago YES/NO
Time frame: at 2 years
Assessment of treatment success
If you were to continue having the same level of symptoms in the next few months, would you consider that acceptable. YES/NO
Time frame: at 2 years