NCT03883477

Endoscopic Trigger Finger Release

Completed NA Results posted Last updated 11 May 2022

What this trial tests

NA trial testing Endoscopic Release in Trigger Finger in 26 participants. Completed in 24 September 2021.

Timeline

13 March 2019

Primary endpoint
24 September 2021

24 September 2021

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	26
Start date	13 March 2019
Primary completion	24 September 2021
Estimated completion	24 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Endoscopic Release
• Standard Open Release

Conditions studied

• Trigger Finger — all drugs for Trigger Finger →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Trigger Finger. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) Primary · 1 Week, 1 Month and 6 Months after surgery

Questionnaires, completed by both the patient and the patient's surgeon/Physician Assistant (PA-C), contain 6 items on a 10-point scale (1 is best, 10 is worst). Scores range from 12 to 120 with 12 indicating normal skin and 120 indicating worst scar imaginable.

1-Week Post-op

Group	Value	95% CI
Endoscopic Release	27.2	± 10.6
Standard Open Release	45.0	± 19.8

1-Month Post-op

Group	Value	95% CI
Endoscopic Release	31.2	± 19.5
Standard Open Release	44.8	± 13.1

6-Months Post-op

Group	Value	95% CI
Endoscopic Release	16.8	± 6.7
Standard Open Release	18.3	± 8.1

Overall Patient Satisfaction: 10 Point Scale Secondary · End of Study (6 months after treatment)

The patient's overall satisfaction after surgery based on a 10 point scale with 1 indicating no satisfaction and 10 indicating extremely satisfied.

Group	Value	95% CI
Endoscopic Release	9.2	± 2.6
Standard Open Release	8.2	± 3.0

Weeks Before Return to Work Secondary · End of study (6 months after treatment)

Number of weeks after surgery before patient returns to work

Group	Value	95% CI
Endoscopic Release	2.6	± 3.0
Standard Open Release	4.4	± 5.7

Duration of Post-operative Therapy Secondary · End of study (6 months after treatment)

Number of days after surgery the patient participates in occupational therapy

Group	Value	95% CI
Endoscopic Release	3.9	± 3.7
Standard Open Release	5.7	± 5.7

Pain Medication Use Secondary · End of Study (6 months after treatment)

Number of days opiates used after surgery

Group	Value	95% CI
Endoscopic Release	0	± 0
Standard Open Release	0.3	± 0.8

Number of Complications Secondary · Through study completion, an average 1 year

Injury to tendons, nerves, or digital vessels, surgical site dehiscence or surgical site infections requiring antibiotics

Group	Value	95% CI
Endoscopic Release	0
Standard Open Release	1

Rate of Recurrence Secondary · At any time point after treatment; through study completion, an average 1 year

Triggering of treated finger, confirmed on physical exam by treating physician, requiring re-operation

Group	Value	95% CI
Endoscopic Release	0
Standard Open Release	1

Sponsor's own description

The purpose of this study is to compare recovery, scar, and patient satisfaction after retrograde endoscopic trigger finger release versus the standard open surgical treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Nonpalmar Endoscopic versus Open Trigger Finger Release: Results from a Prospective Trial.
   Brown AM, Tanabe KL, DellaMaggiora RJ, Tsai EY, et al · · 2022 · cited 2× · PMID 36225845 · DOI 10.1097/gox.0000000000004603