NCT04117516

Brief Summary

Hypothesis: Percutaneous ambulatory carpal tunnel release offers similar outcomes to the open approach in the theatre. Study design: Two-groups randomized single-blind interventional non-inferiority clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

August 11, 2019

Last Update Submit

March 21, 2022

Conditions

Carpal Tunnel Syndrome

Keywords

Percutaneous carpal tunnel release

Outcome Measures

Primary Outcomes (1)

  • Change in Boston Carpal Tunnel Questionnaire

    Outcomes from both interventions will be measured with this symptom severity and functional status carpal tunnel specific scale. The range of the final results are from 19 (no symptoms) to 95 (severe symptoms).

    Preoperative, 4 weeks and 24 weeks after surgery.

Secondary Outcomes (7)

  • Visual Numeric Scale

    Preoperative, 4 weeks and 24 weeks after surgery.

  • Quick-DASH (Disabilities of Arm, Shoulder and Hand)

    Preoperative, 4 weeks and 24 weeks after surgery.

  • Douleur Neuropathique 4 questions (DN4)

    Preoperative, 4 weeks and 24 weeks after surgery.

  • Consumer Reports Effectiveness Scale (CRES-4)

    24 weeks after surgery.

  • Time off work

    24 weeks after surgery.

  • +2 more secondary outcomes

Study Arms (2)

Open surgery

ACTIVE COMPARATOR

30 patients will be operated with an open carpal tunnel release.

Procedure: Open surgery

Percutaneous surgery

EXPERIMENTAL

30 patients will be operated with a percutaneous carpal tunnel release.

Procedure: Percutaneous surgery

Interventions

Open surgeryPROCEDURE

Open carpal tunnel release will be performed, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar "classical" approach of the hand, that allows to visualize the complete division of the ligament.

Open surgery
Percutaneous surgeryPROCEDURE

Percutaneous carpal tunnel release will be performed, ambulatory, with a percutaneous scalpel, through a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.

Percutaneous surgery

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old.
  • Positive electromyography, confirming carpal tunnel syndrome.
  • Capable to understand risks and advantages of both procedures.
  • Normal blood tests.

You may not qualify if:

  • Previous carpal tunnel release in the same hand.
  • Previous fracture or dislocation in the area around the forearm, wrist or hand.
  • Signs or symptoms of infection.
  • Psychiatric disorders.
  • Antiplatelet or anticoagulant therapy, that cannot be suspended due to underlying pathology, and does not allow the surgery to be performed.
  • Coagulation disorders, or any underlying pathology, with high risk of thrombosis or bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Arnau de Vilanova/Lliria

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Conversion to Open Surgery

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

EndoscopyMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

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

Study Record Dates

First Submitted

August 11, 2019

First Posted

October 7, 2019

Study Start

June 5, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

March 22, 2022

Record last verified: 2022-03

Locations

ES(1)