Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement

NCT02236689 | Unknown DMC

• 1 other identifier: 20140553-01H
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.

Conditions

Tennis Elbow

Outcome Measures

Primary Outcomes (1)

• Change in Mayo Elbow Performance Score

  The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.

  From baseline to up until 24-Months Post-Operative

Secondary Outcomes (5)

• Change in Disabilities of the Arm, Shoulder and Hand (DASH)

  From baseline to up until 24-Months Post-Operative

• Change in American Shoulder and Elbow Surgeons Elbow (ASES)

  From baseline to up until 24-Months Post-Operative

• Change in Oxford Elbow Score (OES)

  From time of enrollment up until 2-years post-operative

• Change in Grip Strength

  From time of enrollment up until 2-years post-operative

• Adverse Events

  Ongoing from time of enrollment, up until 24-months post-operative

Study Arms (2)

Arthroscopic tennis elbow release

ACTIVE COMPARATOR

This group will have arthroscopic tennis elbow release through a standard, two-portal technique,

Procedure: Arthroscopic tennis elbow release

Non Operative

PLACEBO COMPARATOR

control group will not undergo a second portal or muscle release.

Procedure: Non operative

Interventions

Non operative PROCEDURE

no surgical intervention

Non Operative

Arthroscopic tennis elbow release PROCEDURE

Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).

Arthroscopic tennis elbow release

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms consistent with lateral epicondylitis persisting for \>6 months, and have failed conservative management
• Adult, skeletally mature (\>18yrs)
• Provision of informed consent

You may not qualify if:

• Alternative diagnosis that better explain their symptoms
• Previous elbow trauma or surgery
• Case involving workplace insurance claims (e.g. WSIB)
• Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
• Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
• Bilateral lateral epicondylitis

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Related Publications (1)

• Matache BA, Berdusco R, Momoli F, Lapner PL, Pollock JW. A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis. BMC Musculoskelet Disord. 2016 Jun 1;17:239. doi: 10.1186/s12891-016-1093-9.

  PMID: 27245219 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• J W Pollock, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J W Pollock, MD

CONTACT

613-737-8899

Katie McIlquham

CONTACT

613-737-8899

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 10, 2014
• Study Start: April 1, 2016
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)