Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession
- Conditions
- Achilles TendinopathyChronic Pain
- Interventions
- Procedure: Proximal Medial Gastrocnemius Recession
- Registration Number
- NCT05179551
- Lead Sponsor
- Ostfold Hospital Trust
- Brief Summary
This is a prospective cohort study that will follow 60 patients treated with Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy for 5 years postoperatively.
- Detailed Description
Mid Portion Achilles Tendinopathy is a condition that usually resolves by itself without any kind of intervention. If the condition becomes chronic, eccentric training guided by a physical therapist seems to be the best non-surgical intervention. Surgical treatment has shown varying results and no gold-standard exists.
Tightness in the gastrocnemius muscle seems to be a contributing factor for many conditions in the foot and ankle region.
Retrospective material suggest that Proximal Medial Gastrocnemius Recession (PMGR) can be an effective treatment for this condition. No prospective material exists.
This study aims at including 60 patients with Chronic Mid-Portion Achilles Tendinopathy (CMPAT) that is non-responsive to eccentric training. Patients will be PMGR-surgery and followed for 5 years with PROMS, muscle function test and MRI scans.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proximal Medial Gastrocnemius Recession Surgery Proximal Medial Gastrocnemius Recession Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.
- Primary Outcome Measures
Name Time Method VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire 5 years A PROM validated for patients with achilles tendon disorders
- Secondary Outcome Measures
Name Time Method Adverse events Baseline, 3 months, 1 year, 2 years, 5 years Infection, thrombosis, nerve injury etc
Assessment of treatment success - pain 2 years Likert question: I have pain in the achilles tendon of the leg that was operated two years ago.
1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly AgreeAssessment of treatment success - Patient Acceptable Symptom State 2 years If you were to continue having the same level of achilles symptoms in the coming few months, would you consider that acceptable? YES/NO
MRI findings pre inclusion versus after 2 years. baseline, 2 years Reduction of intratendinous signal - YES/NO
Eq-5D Baseline, 3 months, 1 year, 2 years, 5 years Quality of life is measured by the EuroQol questionnaire (EQ-5D). 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 five 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).
Assessment of treatment success - other treatments 2 years I have received other treatments for achilles pain since surgery was preformed two years ago YES/NO
Achilles Function Test battery Baseline, 3 months, 2 years The test battery consists of three jump tests, a counter movements jump (CMJ), a drop counter movement jump (drop CMJ) and hopping, and two strength tests, concentric toe-raises, eccentric-concentric toe-raises and toe-raises for endurance. All recorded through the MuscleLab software.
VAS Baseline, 3 months, 1 year, 2 years, 5 years Visual Analogue Scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable.
Assessment of treatment success - physical activity 2 years Likert question: Achilles pain prevents me from performing physical activites
1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly AgreeAnkle Dorsiflexion pre and postoperatively Baseline, 3 months, 2 years measured with a validated goniometer that measures the ankle's range of motion- The device has been previously tested and found to be valid, reliable, and responsive in detecting isolated gastrocnemius contractures (IGCs). An electric goniometer, Biometrics SG150 (Units 25-26, Biometrics Ltd, Newport, UK), with an accuracy of ±2 degrees and a repeatability of 1 degree will be used. The device will be calibrated before every new participant. Force applied directly beneath the head of the second metatarsal until the end range of dorsiflexion with a dynamometer.
Assessment of treatment success - daily living 2 years Likert question: Achilles pain prevents me from performing activities of daily living
1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly AgreeAssessment of treatment success - calf pain 2 years Likert question: I have pain and/or discomfort in the calf muscle that was operated two years ago
1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree
Trial Locations
- Locations (2)
Oslo University Hospital, Orthopedic Department Ullevål
🇳🇴Oslo, Norway
Østfold Hospital Trust
🇳🇴Sarpsborg, Østfold, Norway