N/A
N=26
Endoscopic Trigger Finger Release
Trigger Finger
Bottom Line
View on ClinicalTrials.gov: NCT03883477 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) — 27.2; 45.0; 31.2; 44.8 score on a scale — p=0.013
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic Release (Device); Standard Open Release (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS) |
27.2; 45.0; 31.2; 44.8; 16.8; 18.3 | 0.013 sig |
| SECONDARY Overall Patient Satisfaction: 10 Point Scale |
9.2; 8.2 | 0.142 |
| SECONDARY Weeks Before Return to Work |
2.6; 4.4 | 0.561 |
| SECONDARY Duration of Post-operative Therapy |
3.9; 5.7 | 0.748 |
| SECONDARY Pain Medication Use |
0; 0.3 | 0.184 |
| SECONDARY Number of Complications |
0; 1 | 0.382 |
| SECONDARY Rate of Recurrence |
0; 1 | 0.382 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- Trigger finger diagnosis, recommended for surgical release
- Be in good health other than the trigger finger
- Have realistic expectations of surgical results
- Be willing to undergo surgical or endoscopic treatment
- Understand and be willing to follow all aspects of the study protocol and have signed and dated the Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
Exclusion Criteria
- Collagen-vascular, connective tissue, or bleeding disorder
- Pregnancy
- Regional sympathetic dystrophy
- Abscess or infection at time of planned surgery
- Have a condition or be in a situation that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Data sourced from ClinicalTrials.gov (NCT03883477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.