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

Endoscopic versus Open Cubital Tunnel Release: An Open Randomized Clinical Trial - EVOCU Trial: Endoscopic Versus Open CUbital tunnel release

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50856

Enrollment

160

Registered

2021-03-24

Start date

2022-02-11

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

compression of the nerve at the elbow Cubital Tunnel Syndrome

Interventions

An open or endoscopic cubital tunnel release. Both the open and endoscopic cubital tunnel release are common clinical practice in patients having cubital tunnel syndrome. In the Jeroen Bosch Ziekenh

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The difference in change (Δ, preoperatively and postoperatively) in BCTQ score between both treatment groups at 3, 12 and 18 months follow-up.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)