Recruiting

Arthroscopic Tennis Elbow Release vs. Arthroscopic Debridement

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT02236689

Conditions

Tennis Elbow

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Non operative

Arthroscopic tennis elbow release

Study Details

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

Study ID

NCT02236689

Start date

Apr, 2016

Status verified date

Nov, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arthroscopic tennis elbow release

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

placebo comparator: Non Operative

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

Interventions

Non operative

no surgical intervention

Arthroscopic tennis elbow release

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).

Primary outcome measure

  • Change in Mayo Elbow Performance Score [ Time Frame: From baseline to up until 24-Months Post-Operative ]

Central Contacts and Locations

Central contacts

J W Pollock, MD

613-737-8899

Katie McIlquham

613-737-8899

Locations

The Ottawa Hospital, General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

J Pollock, MD

613-737-8899

Principal Investigator:

J W Pollock, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Nov 13, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2023-11-13.