Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
Condition: Epicondylitis of the Elbow; Tennis Elbow
MeSH terms: Tennis Elbow
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mini-open surgery; Ultrasound-guided Tendon fenestration
Intervention type(s): Procedure; Device
Intervention description(s): This treatment will be administered by an orthopedic surgeon specialized in upper limb surgery.
Skin disinfection; Local anesthesia (lidocaine 1%).
Skin incision, slightly anterior to lateral epicondyle.
Exposure of the plane between the tendon and fascia.
Extensor Carpi Radialis Longus (ECRL) tendon is lifted to expose the Extensor Carpi Radialis Brevis (ECRB) tendon.
Excision of diseased tissue of the ECRB tendon.
ECRL tendon is sutured back to the fascia. The skin is closed.
Patient is monitored for 30 minutes after procedure.; This treatment will be administered by a fellowship-trained MSK radiologist.
Patient's elbow at 70 degrees of flexion with the forearm pronated resting on an examination table.
Skin disinfection. Local anesthesia, skin, superficial fascia and tendon, with lidocaine 1%.
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.
Patient monitored for 30 minutes, before being discharged.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral Epicondylitis of the elbow; Tendon Fenestration; Minimally invasive Surgery; Ultrasound-guided procedure; Ultrasonography; Elastography