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Achilles TendinopathyNCT05179551

Achillestendinopathy Treated With Proximal Medial Gastrocnemius Recession

A study testing Proximal Medial Gastrocnemius Recession in people with Achilles Tendinopathy and Chronic Pain, run by Ostfold Hospital Trust at 2 sites in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Achilles Tendinopathy, Chronic Pain
What is being tested?
Proximal Medial Gastrocnemius Recession
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesNorway
Study dates
31 Dec 2021to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Martin O Riiser, MD contact

+4797146230

riiser.martin@gmail.com

Marius Molund, MD PhD contact

+4790003099

mariusmolund@hotmail.com

Norway2 sites, 2 recruiting

  • Oslo University Hospital, Orthopedic Department Ullevål

    Oslo, 1714

    Martin O Riiser, MD, +4797146230, riiser.martin@gmail.com

    Elisabeth Ellingsen Husebye, PhD, +4795195276, uxngng@ous-hf.no

    Recruiting

  • Østfold Hospital Trust

    Sarpsborg, Østfold fylke, 1714

    Martin O Riiser, MD, +4797146230, riiser.martin@gmail.com

    Marius Molund, PhD, +4790093988, mariusmolund@hotmail.com

    Recruiting

Other trials in Norway

About this study

Official title: Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy; A Multicenter, Prospective Cohort Study.

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.

Read the 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.

Being tested
Proximal Medial Gastrocnemius Recession
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proximal Medial Gastrocnemius RecessionProcedure or surgery

    Also called PMGR

    . 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

Study groups in NCT05179551
Study groupRoleWhat they receive
Proximal Medial Gastrocnemius Recession SurgeryExperimentalPatients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.
Receives: Procedure: Proximal Medial Gastrocnemius Recession

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

    A PROM validated for patients with achilles tendon disorders

    Measured: Baseline

  2. VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

    A PROM validated for patients with achilles tendon disorders

    Measured: 3 months

  3. VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

    A PROM validated for patients with achilles tendon disorders

    Measured: 1 year

  4. VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

    A PROM validated for patients with achilles tendon disorders

    Measured: 2 years

  5. VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire

    A PROM validated for patients with achilles tendon disorders

    Measured: 5 years

Secondary outcomes (13)

  1. 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.

    Measured: Baseline, 3 months, 2 years

  2. 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.

    Measured: Baseline, 3 months, 2 years

  3. MRI findings pre inclusion versus after 2 years.

    1. Tendon thickness - Thickest point anterior-posteriorly in the sagittal plane in millimeters. Cm2 at thickest point in the axial plane.

    Measured: Baseline, 2years

  4. 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.

    Measured: Baseline, 3 months, 1 year, 2 years, 5 years

  5. 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).

    Measured: Baseline, 3 months, 1 year, 2 years, 5 years

  6. Adverse events

    Infection, thrombosis, nerve injury etc

    Measured: Baseline, 3 months, 1 year, 2 years, 5 years

  7. MRI findings pre inclusion versus after 2 years.

    Reduction of intratendinous signal - YES/NO

    Measured: baseline, 2 years

  8. 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

    Measured: 2 years

  9. 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

    Measured: 2 years

  10. 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

    Measured: 2 years

  11. 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

    Measured: 2 years

  12. Assessment of treatment success - other treatments

    I have received other treatments for achilles pain since surgery was preformed two years ago YES/NO

    Measured: 2 years

  13. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start31 Dec 2021
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective Cohort Study
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179551
Sponsor's protocol ID
REK244374
Status last verified
Mar 2024
First submitted
21 Oct 2021
Last updated
8 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Proximal Medial Gastrocnemius Recession in people with Achilles Tendinopathy and Chronic Pain, run by Ostfold Hospital Trust at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Martin O Riiser, MD (+4797146230, riiser.martin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05179551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.

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