NCT02766114

Brief Summary

Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2013

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

February 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

May 4, 2016

Last Update Submit

May 6, 2016

Conditions

Keywords

CTSCarpal tunnel syndromeCarpal tunnel releaseMini incision of carpal tunnel releaseCosmetic surgery of carpal tunnel syndromeendoscopic carpal tunnel surgeryCarpal Tunnel Release Through Mini Transverse ApproachDr. Sayed Issa's ApproachCTRMTAOCTRECTROpen Carpal Tunnel ReleaseEndoscopic Carpal Tunnel ReleaseSyriaCosmeticSafetyRehabilitation,ComplicationsSurgerySatisfaction

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with post surgical trauma

    Up to eight weeks

Secondary Outcomes (2)

  • Duration of rehabilitation period

    Up to three weeks

  • Proportion of patients with cosmetic scar

    Up to 6 months

Study Arms (1)

Issa1

EXPERIMENTAL

After local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist.

Procedure: Carpal tunnel release through Mini Transverse Approach

Interventions

Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.

Issa1

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
  • Participant cooperation sufficient to operate under local anesthesia

You may not qualify if:

  • Un controlled diabetes mellitus type 1 and 2
  • Patients with non controlled Vascular hypertension
  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
  • Patients with history of Carpal Tunnel release surgery failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Sayed Issa's Clinic

Aleppo, Syria

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromePersonal Satisfaction

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 9, 2016

Study Start

February 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations