Clinical trial NCT06267105: A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Disturbance as Result
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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...).

Primary outcomes:
measure: Functional improvement of the patient after surgery
timeFrame: Immediately after surgery
Secondary outcomes:
measure: Surgeon comfort
timeFrame: Immediately after surgery
measure: Resolution
timeFrame: 1, 3 and 6 months
measure: Flushed
timeFrame: 1, 3 and 6 months
measure: Pain feeling
timeFrame: 1, 3 and 6 months
measure: Contracture
timeFrame: 1, 3 and 6 months
measure: Infection
timeFrame: 1, 3 and 6 months
measure: Nerve injury
timeFrame: 1, 3 and 6 months
measure: Return to work
timeFrame: 1, 3 and 6 months
measure: Reincorporation to activities
timeFrame: 1, 3 and 6 months
measure: Sensitivity Test
timeFrame: 1, 3 and 6 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc taulí
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.