Back to resultsAchillestendinopathy Treated With Proximal Medial Gastrocnemius Recession
Primary Purpose
Achilles Tendinopathy, Chronic Pain
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Proximal Medial Gastrocnemius Recession
Sponsored by
About this trial
This is an interventional treatment trial for Achilles Tendinopathy
Eligibility Criteria
Inclusion criteria:
- Age 18-75 years.
- Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
- Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
- Duration of symptoms must be at least 12 months.
- Isolated gastrocnemius tightness must be verified with the Silfverskiölds test before inclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee.
- At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.
Exclusion criteria:
- Previous history of complete Achilles tendon rupture.
- Other combined pathologies in the Achilles tendon of calf (Sequela from trauma, infections, cancer etc.).
- Insertional Achilles tendinopathy.
- Previously undergone surgery in affected tendon.
- Patients with severe talocrural pathology or serious malalignment of foot and ankle.
- Severely reduced peripheral circulation.
- History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- Patients with a contraindication/non-compliance for MRI examination.
- History of allergic reaction/anaphylactic reaction to local anesthetics.
- Not able to read and/or speak a Scandinavian language or English adequately.
- Other serious comorbidity that makes surgery unadvisable.
Sites / Locations
- Oslo University Hospital, Orthopedic Department UllevålRecruiting
- Østfold Hospital TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proximal Medial Gastrocnemius Recession Surgery
Arm Description
Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.
Outcomes
Primary Outcome Measures
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
A PROM validated for patients with achilles tendon disorders
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
A PROM validated for patients with achilles tendon disorders
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
A PROM validated for patients with achilles tendon disorders
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
A PROM validated for patients with achilles tendon disorders
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
A PROM validated for patients with achilles tendon disorders
Secondary Outcome Measures
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.
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.
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.
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.
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).
Adverse events
Infection, thrombosis, nerve injury etc
MRI findings pre inclusion versus after 2 years.
Reduction of intratendinous signal - YES/NO
Full Information
NCT ID
NCT05179551
First Posted
October 21, 2021
Last Updated
January 16, 2023
Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05179551
Brief Title
Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession
Official Title
Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy; A Multicenter, Prospective Cohort Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 31, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective Cohort Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Proximal Medial Gastrocnemius Recession Surgery
Arm Type
Experimental
Arm Description
Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.
Intervention Type
Procedure
Intervention Name(s)
Proximal Medial Gastrocnemius Recession
Other Intervention Name(s)
PMGR
Intervention Description
. 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
Primary Outcome Measure Information:
Title
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
Description
A PROM validated for patients with achilles tendon disorders
Time Frame
Baseline
Title
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
Description
A PROM validated for patients with achilles tendon disorders
Time Frame
3 months
Title
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
Description
A PROM validated for patients with achilles tendon disorders
Time Frame
1 year
Title
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
Description
A PROM validated for patients with achilles tendon disorders
Time Frame
2 years
Title
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
Description
A PROM validated for patients with achilles tendon disorders
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Achilles Function Test battery
Description
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.
Time Frame
Baseline, 3 months, 2 years
Title
Ankle Dorsiflexion pre and postoperatively
Description
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.
Time Frame
Baseline, 3 months, 2 years
Title
MRI findings pre inclusion versus after 2 years.
Description
a. Tendon thickness - Thickest point anterior-posteriorly in the sagittal plane in millimeters. Cm2 at thickest point in the axial plane.
Time Frame
Baseline, 2years
Title
VAS
Description
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, 3 months, 1 year, 2 years, 5 years
Title
Eq-5D
Description
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).
Time Frame
Baseline, 3 months, 1 year, 2 years, 5 years
Title
Adverse events
Description
Infection, thrombosis, nerve injury etc
Time Frame
Baseline, 3 months, 1 year, 2 years, 5 years
Title
MRI findings pre inclusion versus after 2 years.
Description
Reduction of intratendinous signal - YES/NO
Time Frame
baseline, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18-75 years.
Diagnosis CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
Duration of symptoms must be at least 12 months.
Isolated gastrocnemius tightness must be verified with the Silfverskiölds test before inclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee.
At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.
Exclusion criteria:
Previous history of complete Achilles tendon rupture.
Other combined pathologies in the Achilles tendon of calf (Sequela from trauma, infections, cancer etc.).
Insertional Achilles tendinopathy.
Previously undergone surgery in affected tendon.
Patients with severe talocrural pathology or serious malalignment of foot and ankle.
Severely reduced peripheral circulation.
History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
Patients with a contraindication/non-compliance for MRI examination.
History of allergic reaction/anaphylactic reaction to local anesthetics.
Not able to read and/or speak a Scandinavian language or English adequately.
Other serious comorbidity that makes surgery unadvisable.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin O Riiser, MD
Phone
+4797146230
Email
riiser.martin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marius Molund, MD PhD
Phone
+4790003099
Email
mariusmolund@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Molund, PhD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Orthopedic Department Ullevål
City
Oslo
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin O Riiser, MD
Phone
+4797146230
Email
riiser.martin@gmail.com
First Name & Middle Initial & Last Name & Degree
Elisabeth Ellingsen Husebye, PhD
Phone
+4795195276
Email
uxngng@ous-hf.no
Facility Name
Østfold Hospital Trust
City
Sarpsborg
State/Province
Østfold
ZIP/Postal Code
1714
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin O Riiser, MD
Phone
+4797146230
Email
riiser.martin@gmail.com
First Name & Middle Initial & Last Name & Degree
Marius Molund, PhD
Phone
+4790093988
Email
mariusmolund@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession
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