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Completed

NCT Number: NCT03883477

Endoscopic Trigger Finger Release

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.

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Key information

Conditions

Trigger Finger Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Entrapment Tendon Injuries Trigger Finger Disorder Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Department of Orthopedic Surgery

Los Angeles, California, 90048, United States

About this study

Consecutive patients presenting with trigger finger interested in surgical release of the A1 pulley will be prospectively treated with endoscopic versus open surgical release of the A1 pulley. Study measures will include scar assessment based on the Patient and Observer Scar Assessment Scale (POSAS) administered at 1 week, 1 month, and 6 months post-operatively, overall satisfaction (scale of 1 to 10), days before return to work, duration of post-operative occupational therapy, pain medication use, operative time, and complication and recurrence rates.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Release

Device

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.

Standard Open Release

Procedure

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Overall Patient Satisfaction: 10 Point Scale

    Time frame: 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.

  2. Weeks Before Return to Work

    Time frame: End of study (6 months after treatment)

    Number of weeks after surgery before patient returns to work

  3. Duration of Post-operative Therapy

    Time frame: End of study (6 months after treatment)

    Number of days after surgery the patient participates in occupational therapy

  4. Pain Medication Use

    Time frame: End of Study (6 months after treatment)

    Number of days opiates used after surgery

  5. Number of Complications

    Time frame: Through study completion, an average 1 year

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

  6. Rate of Recurrence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2019
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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