NCT03883477

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2021

Completed
8 months until next milestone

Results Posted

Study results publicly available

May 11, 2022

Completed
Last Updated

May 11, 2022

Status Verified

April 1, 2022

Enrollment Period

2.5 years

First QC Date

March 15, 2019

Results QC Date

January 3, 2022

Last Update Submit

April 16, 2022

Conditions

Trigger Finger

Keywords

TendinopathyTrigger Finger

Outcome Measures

Primary Outcomes (1)

  • Scar Comparison Between Treatment Arms, as Measured by the Patient and Observer Scar Assessment Scale (POSAS)

    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, 1 Month and 6 Months after surgery

Secondary Outcomes (6)

  • Overall Patient Satisfaction: 10 Point Scale

    End of Study (6 months after treatment)

  • Weeks Before Return to Work

    End of study (6 months after treatment)

  • Duration of Post-operative Therapy

    End of study (6 months after treatment)

  • Pain Medication Use

    End of Study (6 months after treatment)

  • Number of Complications

    Through study completion, an average 1 year

  • +1 more secondary outcomes

Study Arms (2)

Endoscopic Release

EXPERIMENTAL

12 patients recommended for surgical treatment of trigger finger will undergo endoscopic release.

Device: Endoscopic Release

Standard Open Release

ACTIVE COMPARATOR

12 patients recommended for surgical treatment of trigger finger will undergo standard open surgical release.

Procedure: Standard Open Release

Interventions

Endoscopic ReleaseDEVICE

Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices.

Endoscopic Release
Standard Open ReleasePROCEDURE

Standard open surgical release of the A1 pulley for treatment of trigger finger.

Standard Open Release

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Department of Orthopedic Surgery

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Trigger Finger DisorderTendinopathy

Condition Hierarchy (Ancestors)

Tendon EntrapmentMuscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Limitations and Caveats

Lack of randomization and blinding.

Results Point of Contact

Title
Clinical Trial RN
Organization
Cedars-Sinai Medical Center, Department of Orthopedic Surgery
rodriquezsv@csmns.org
3104235900

Study Officials

  • David A Kulber, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 21, 2019

Study Start

March 13, 2019

Primary Completion

September 24, 2021

Study Completion

September 24, 2021

Last Updated

May 11, 2022

Results First Posted

May 11, 2022

Record last verified: 2022-04

Locations

US(1)