Endoscopic versus Open Cubital Tunnel Release: An Open Randomized Clinical Trial

Recruiting

• Conditions: compression of the nerve at the elbow; Cubital Tunnel Syndrome; 10034606; 10009720

• Registration Number: NL-OMON50856
• Lead Sponsor: Plastische Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

- Idiopathic ulnar nerve entrapment at elbow, objectified clinically, with an
electrophysiologic confirmed (EMG) diagnosis;
- Ability to measure the outcome of the study in this patient (e.g. life
expectancy > 1 year, no planned relocation);
- Ability to speak and understand Dutch;
- Informed consent.

Exclusion Criteria

- Age under 18;
- Not able to provide informed consent;
- Previous surgical cubital tunnel release or other surgery performed in the
same elbow;
- Subluxation palpable during elbow flexion pre-operatively or occurring during
surgery after release for which a transposition of the ulnar nerve is needed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in change (&Delta;, preoperatively and postoperatively) in BCTQ score<br /><br>between both treatment groups at 3, 12 and 18 months follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The difference in change (&Delta;, preoperatively and postoperatively) in PRUNE<br /><br>score between both treatment groups at 3, 12 and 18 months follow-up;<br /><br>- The difference in PREM between both treatment groups at 3 months follow-up<br /><br>and its correlation with the change (&Delta;, preoperatively and postoperatively) in<br /><br>PROM;<br /><br>- The difference in post-operative recovery of sensibility between both<br /><br>treatment groups at 3 and 12 months follow-up;<br /><br>- The difference in return to work/full activity in days between both treatment<br /><br>groups;<br /><br>- The difference in amount of complications between both treatment groups<br /><br>during the follow-up period of 18 months;<br /><br>- The difference in scar aesthetics between both treatment groups at 6 weeks<br /><br>and 12 months follow-up;<br /><br>- The difference in correlation between VAS score, Bishop score,<br /><br>two-point discrimination and both PROMS (BCTQ and PRUNE). </p><br>