Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement

NCT ID: NCT02236689

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2025-12-31

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.

Detailed Description

Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.

Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.

Conditions

Tennis Elbow

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arthroscopic tennis elbow release

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

Group Type: ACTIVE_COMPARATOR

Arthroscopic tennis elbow release

Intervention Type: 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).

Non Operative

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

Group Type: PLACEBO_COMPARATOR

Non operative

Intervention Type: PROCEDURE

no surgical intervention

Interventions

Non operative

no surgical intervention

Intervention Type: PROCEDURE

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).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

J W Pollock, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

J W Pollock, MD

Role: CONTACT

613-737-8899 ext. 73031

Katie McIlquham

Role: CONTACT

613-737-8899 ext. 79839

Facility Contacts

J Pollock, MD

Role: primary

613-737-8899 ext. 73031

References

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.

Reference Type: DERIVED

PMID: 27245219 (View on PubMed)

Other Identifiers

20140553-01H

Identifier Type: -

Identifier Source: org_study_id