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| Name | Class |
|---|---|
| Oslo University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal Medial Gastrocnemius Recession Surgery | Experimental | Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proximal Medial Gastrocnemius Recession | Procedure | . 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire | A PROM validated for patients with achilles tendon disorders | Baseline |
| VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire | A PROM validated for patients with achilles tendon disorders | 3 months |
| VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire | A PROM validated for patients with achilles tendon disorders | 1 year |
| VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire | A PROM validated for patients with achilles tendon disorders | 2 years |
| VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire | A PROM validated for patients with achilles tendon disorders | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Achilles Function Test battery | 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. | Baseline, 3 months, 2 years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin O Riiser, MD | Contact | +4797146230 | riiser.martin@gmail.com | |
| Marius Molund, MD PhD | Contact | +4790003099 | mariusmolund@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marius Molund, PhD | Ostfold Hospital Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Orthopedic Department Ullevål | Recruiting | Oslo | 1714 | Norway |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Prospective Cohort Study
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| Ankle Dorsiflexion pre and postoperatively | 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. | Baseline, 3 months, 2 years |
| MRI findings pre inclusion versus after 2 years. | a. Tendon thickness - Thickest point anterior-posteriorly in the sagittal plane in millimeters. Cm2 at thickest point in the axial plane. | Baseline, 2years |
| VAS | Visual Analogue Scale for pain during use of affected leg in the last 24 hours. 0 is no pain. 10 is worst pain imaginable. | Baseline, 3 months, 1 year, 2 years, 5 years |
| Eq-5D | 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). | Baseline, 3 months, 1 year, 2 years, 5 years |
| Adverse events | Infection, thrombosis, nerve injury etc | Baseline, 3 months, 1 year, 2 years, 5 years |
| MRI findings pre inclusion versus after 2 years. | Reduction of intratendinous signal - YES/NO | baseline, 2 years |
| Assessment of treatment success - pain | 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 Agree | 2 years |
| Assessment of treatment success - physical activity | Likert question: Achilles pain prevents me from performing physical activites 1) Strongly Disagree; (2) Disagree; (3) Neither Agree nor Disagree; (4) Agree; (5) Strongly Agree | 2 years |
| Assessment of treatment success - daily living | 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 Agree | 2 years |
| Assessment of treatment success - calf pain | 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 | 2 years |
| Assessment of treatment success - other treatments | I have received other treatments for achilles pain since surgery was preformed two years ago YES/NO | 2 years |
| Assessment of treatment success - Patient Acceptable Symptom State | If you were to continue having the same level of achilles symptoms in the coming few months, would you consider that acceptable? YES/NO | 2 years |
| Østfold Hospital Trust | Recruiting | Sarpsborg | Østfold fylke | 1714 | Norway |
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