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Trial record 25 of 111 for:    tendon | Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis

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ClinicalTrials.gov Identifier: NCT02710682
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Nathalie Bureau, Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent, painful syndrome of the elbow. It is refractory to conservative treatment measures, including rest, excentric and concentric exercises in approximately 20% of patients after 6 months. Corticosteroid injections can provide relief in the short term. Mini-open surgery may be proposed when the conservative treatment fails and studies have shown an efficacy of 70%. Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the physiological healing mechanisms of the tendon and appears promising for the treatment of chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration technique to mini-open surgery for the treatment of chronic lateral epicondylosis.

The primary objective of this pilot study is to compare the efficacy of US-guided fenestration to mini-open surgery to reduce pain and improve functional status in workers suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.

This is a prospective single-blind randomized pilot study. Sixty-four subjects will be randomized into two intervention groups for treatment either by US-guided fenestration or mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow Evaluation (PRTEE) score at 6 month post-procedure.


Condition or disease Intervention/treatment Phase
Epicondylitis of the Elbow Tennis Elbow Procedure: Mini-open surgery Device: Ultrasound-guided Tendon fenestration Not Applicable

Detailed Description:

STUDY DESIGN:

Phase II, prospective, two-arm, single-blind randomized controlled study.

SETTING:

Up to 64 patients (56 + 15% loss to follow-up) suffering from chronic lateral epicondylosis will be recruited by one of two orthopedists working in a specialized outpatient clinic, at the Centre Hospitalier de l'Université de Montréal (CHUM), a tertiary care academic center. Ultrasound examination of the elbow will be performed before the interventions.

RANDOMIZATION:

Using a computerized randomization list, the subjects will be randomized into the 2 treatment arms to be treated either by an US-guided tendon fenestration technique or by mini-open surgery. Randomization will be stratified by block sizes of 8.

FOLLOW UP Subjects' follow-up will extend over a period of 12 months - i.e., at 6 weeks and 3, 6 and 12 months post-intervention. The primary outcome will be the PRTEE score. Secondary outcomes will evaluate the impact of each procedure on: Pain-free grip (dynamometer), Medication Quantitative Scale, working activity (QuickDASH general and work modules; RA-WIS), Patient Global Impression of Change and Patient Satisfaction. The ultrasound examination will be repeated at 6 and 12 months. The predictive value of various B-mode parameters, color Doppler and elastography will be explored.

ANALYSIS:

The primary endpoint will be the proportion of subjects in each intervention arm presenting a reduction of at least 11/100 of the PRTEE score at 6 months post-intervention. The Fisher's exact test will be used to compare the proportion of subjects in each treatment group. The primary analysis will follow the intention-to-treat principle. Regarding the secondary endpoints, an ANOVA for repeated measures with two factors (time and group), a Fisher's exact test or a recursive partitioning analysis will be performed as appropriate.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Tendon Fenestration Versus Open Surgery for the Treatment of Chronic Lateral Epicondylosis of the Elbow: a Prospective, Randomized, Single Blind, Pilot Study.
Study Start Date : May 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Mini-open surgery
Surgery
Procedure: Mini-open surgery

This treatment will be administered by an orthopedic surgeon specialized in upper limb surgery.

  1. Skin disinfection; Local anesthesia (lidocaine 1%).
  2. Skin incision, slightly anterior to lateral epicondyle.
  3. Exposure of the plane between the tendon and fascia.
  4. Extensor Carpi Radialis Longus (ECRL) tendon is lifted to expose the Extensor Carpi Radialis Brevis (ECRB) tendon.
  5. Excision of diseased tissue of the ECRB tendon.
  6. ECRL tendon is sutured back to the fascia. The skin is closed.
  7. Patient is monitored for 30 minutes after procedure.

Experimental: Ultrasound-guided Tendon fenestration
Tendon fenestration
Device: Ultrasound-guided Tendon fenestration

This treatment will be administered by a fellowship-trained MSK radiologist.

  1. Patient's elbow at 70 degrees of flexion with the forearm pronated resting on an examination table.
  2. Skin disinfection. Local anesthesia, skin, superficial fascia and tendon, with lidocaine 1%.
  3. Using a 22 G needle under continuous ultrasound guidance, several passes (about 20-30) within the abnormal area of the tendon, contacting the bone, until the area softens.
  4. Patient monitored for 30 minutes, before being discharged.




Primary Outcome Measures :
  1. Proportion of patients with a change of at least 11/100 points in the score of the Patient Rated Tennis Elbow Evaluation - 6 months [ Time Frame: Baseline and 6 months post-intervention ]

Secondary Outcome Measures :
  1. Patient Rated Tennis Elbow Evaluation [ Time Frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention ]

    Proportion of patients with a change of at least 11/100 points in the score over the time.

    Mean change in the score over the time.


  2. QuickDASH main module [ Time Frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention ]

    Proportion of patients with a change of at least 8/100 points in the score over the time.

    Mean change in the score over the time.


  3. QuickDASH Work module [ Time Frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention ]

    Proportion of patients with a change of at least 8/100 points in the score over the time.

    Mean change in the score over the time.


  4. RA-WIS questionnaire [ Time Frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention ]
    Proportion of patients with score of at least 17 points over the time. Mean change in the score over the time.

  5. Grip strength without pain [ Time Frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention ]
    Mean change over the time

  6. Medication Quantitative Scale [ Time Frame: 6 weeks, 3 months, 6 months and 12 months post-intervention ]
    Mean change over the time

  7. Global Perception of Change [ Time Frame: 6 weeks, 3 months, 6 months and 12 months post-intervention ]
    Proportion of patients reporting that their condition has significantly or moderately improved over the time

  8. Level of satisfaction [ Time Frame: 6 weeks, 3 months, 6 months and 12 months post-intervention ]
    Proportion of patients reporting that their condition has significantly or moderately satisfied over the time

  9. Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound [ Time Frame: Baseline, 6 and 12 months post-intervention ]
    Recursive partitioning analysis

  10. Common Extensor Tendon Elasticity measured at ultrasound elastography [ Time Frame: Baseline, 6 and 12 months post-intervention ]
    Recursive partitioning analysis



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Workers
  • Ability to read, understand and answer questionnaires in French or English
  • Diagnosis of unilateral, lateral epicondylosis established by an orthopaedist, determined by clinical presentation and pain, ≥ 4/10 on a pain numerical rating scale, on palpation of the region slightly anterior and distal to the lateral epicondyle, exacerbated by the extension of the wrist or the middle finger when the elbow is in extension.
  • Chronic epicondylosis, refractory to medical treatment conducted for at least six months, which includes rest and implementation of ergonomics to avoid soliciting the extensor tendons, and at least one of: physical therapy, a rehabilitation program with stretching and / or strengthening exercises, injection treatments (corticosteroids, autologous PRP) or extracorporeal shock waves.

Exclusion Criteria:

  • Suspected tumor or infectious etiology
  • Injection of corticosteroids during the last 3 months
  • Hemorrhagic diathesis; anticoagulation (platelets <50,000, International Normalized Ratio (INR) > 2)
  • Local infection
  • History of elbow surgery or fracture
  • History of inflammatory arthropathy
  • Neck pain and radiculopathy
  • Inability to provide informed consent because of a language problem, dementia or a major psychiatric disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710682


Contacts
Contact: Nathalie Bureau, MD, MSc 5148908000 ext 8444 Nathalie.Bureau@umontreal.ca
Contact: Elisabeth Martin, MSc 5148908000 ext 15492 elisabeth.martin.chum@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre Recherche du CHUM Recruiting
Montreal, Quebec, Canada, H2W1T8
Contact: Elisabeth Martin, M.Sc.    514-890-8000 ext 15492    elisabeth.martin.chum@ssss.gouv.qc.ca   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Nathalie Bureau, MD, MSc CRCHUM

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nathalie Bureau, Researcher, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02710682     History of Changes
Other Study ID Numbers: CE 15.327
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nathalie Bureau, Centre hospitalier de l'Université de Montréal (CHUM):
Lateral Epicondylitis of the elbow
Tendon Fenestration
Minimally invasive Surgery
Ultrasound-guided procedure
Ultrasonography
Elastography

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries