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Ultrasound Guided A1 Pulley Release For The Treatment of Trigger Finger

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ClinicalTrials.gov Identifier: NCT02830672
Recruitment Status : Active, not recruiting
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of A1 pulley. Results will be compared regarding functional, clinical and cosmetic outcome.

Condition or disease Intervention/treatment Phase
Surgical Release of Ai Pulley Trigger Finger Procedure: Surgical release A1 pulley for Trigger finger of the hand Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Open surgical release A1 Pulley Procedure: Surgical release A1 pulley for Trigger finger of the hand
Active Comparator: Ultrasound guided close release A1 pulley Procedure: Surgical release A1 pulley for Trigger finger of the hand


Outcome Measures

Primary Outcome Measures :
  1. Resolution of triggering expressed as the "success rate" per digit. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The time for taking postoperative pain killers [ Time Frame: 12 weeks ]
  2. Range of motion recovery [ Time Frame: 12 weeks ]
  3. QuickDASH test scores (Greek version) [ Time Frame: 12 weeks ]
  4. Time to return to normal activities (including work) [ Time Frame: 12 weeks ]
  5. Cosmetic results [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months.

Exclusion Criteria:

  • Patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease.
  • Patients with multiple trigger fingers
More Information

Responsible Party: Vasileios S. Nikolaou, Assistant Professor Of Orthopedics, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02830672     History of Changes
Other Study ID Numbers: 1
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Trigger Finger Disorder
Tendon Entrapment
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases