A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Longitudinal incision, Transverse incision.
- Who it may be relevant to
- Registry conditions: Functional Disturbance as Result. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study to Compare Functional Results in Patients Affected by Trigger Finger When Surgery is Performed Through a Transverse or Longitudinal Surgical Incision in the Skin.
Overview
Trigger finger is a common pathology in the hand. Patients suffer from pain and depending on which tasks, patients have difficulty to perform them. Its treatment in initial and less serious phases includes conservative measures, but failure of these may require releasing the trigger finger with surgery. The surgical technique performed for trigger finger is the opening of the A1 pulley, the skin incisions used for this surgery are various (transverse, longitudinal, oblique). Trigger finger surgery presents good results in terms of resolution, but complications may also occur. The reason for this study is to assess whether there are functional differences using the Dash scale when we perform a transverse or longitudinal incision in trigger finger surgery.
Interventions
- Procedure Longitudinal incision
Incision performed longitudinally - Procedure Transverse incision
Incision performed transversally
Primary outcome measures
- Functional improvement of the patient after surgery [Time frame: Immediately after surgery]
Secondary outcome measures (10)
- Surgeon comfort [Time frame: Immediately after surgery]
- Resolution [Time frame: 1, 3 and 6 months]
- Flushed [Time frame: 1, 3 and 6 months]
- Pain feeling [Time frame: 1, 3 and 6 months]
- Contracture [Time frame: 1, 3 and 6 months]
- Infection [Time frame: 1, 3 and 6 months]
- Nerve injury [Time frame: 1, 3 and 6 months]
- Return to work [Time frame: 1, 3 and 6 months]
- Reincorporation to activities [Time frame: 1, 3 and 6 months]
- Sensitivity Test [Time frame: 1, 3 and 6 months]
Eligibility criteria
Inclusion criteria
- Patients over 18 years of age.
- Clinical diagnosis of trigger finger grade II to IV.
Grade I (pre-trigger) Pain, history of entrapment, but not demonstrable on physical examination, tenderness over the A1 pulley.
Grade II (active) Demonstrable entrapment, but the patient can actively extend the finger.
Grade III (passive) Demonstrable entrapment, patient requires passive extension IIIA or inability to actively flex IIIB.
Grade IV (contracture) Demonstrable entrapment with fixed flexion contracture of the PIP.
Exclusion criteria
- Thumb
- Polydigital
- Allergy to local anesthetics and/or vasoconstrictor agents.
- Previous surgery
- Patients who, in the researcher's opinion, are not good candidates for the study (e.g. inability to comply with the follow-up program, comorbidity, poor physical or mental health in general, drug or alcohol abuse problems...).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Parc taulí — Sabadell
Publications
- Mohd Rashid MZ, Sapuan J, Abdullah S. A randomized controlled trial of trigger finger release under digital anesthesia with (WALANT) and without adrenaline. J Orthop Surg (Hong Kong). 2019 Jan-Apr;27(1):2309499019833002. doi: 10.1177/2309499019833002. PMID 30852960
- Kazmers NH, Holt D, Tyser AR, Wang A, Hutchinson DT. A prospective, randomized clinical trial of transverse versus longitudinal incisions for trigger finger release. J Hand Surg Eur Vol. 2019 Oct;44(8):810-815. doi: 10.1177/1753193419859375. Epub 2019 Jul 4. PMID 31272265
- Kloeters O, Ulrich DJ, Bloemsma G, van Houdt CI. Comparison of three different incision techniques in A1 pulley release on scar tissue formation and postoperative rehabilitation. Arch Orthop Trauma Surg. 2016 May;136(5):731-7. doi: 10.1007/s00402-016-2430-z. Epub 2016 Feb 29. PMID 26926477
Identifiers
NCT: NCT06267105 · A1-LORT