NCT03168646

Brief Summary

there are many management options of ulnocarpal abutment depends on clinical evaluation and imaging of this joint. Arthroscopic treatment is the simplest solution for these conditions.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

May 16, 2017

Last Update Submit

May 26, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • mayo scoring system

    follow up of the pain( nonpain,mild occasional, moderate and sever graded as 1,2,3,4 respectively

    6 month

  • mayo scoring system

    Range of motion of the wrist compared to the normal side(100 ,75-99,50-74,25-9,0-24%

    6 month

  • mayo scoring system

    grip strength

    6 month

Study Arms (2)

group 1

ACTIVE COMPARATOR

wafer group procedure using an arthroscope through portal(radial to extensor carpi ulnaris, debridement of triangular fibro-cartilage complex 3-4 mm is shaved from the dome of the ulna by 2.9 bur.

Procedure: wafer procedure

group 2

ACTIVE COMPARATOR

ulnar shortening group :this is the most logical technique, dorsoulnar incision is made on the distal one-third of the forearm then a 6 hole 3.5 mm Dcp plate is position,osteotomy using oscillating saw in z-shaped manner.

Procedure: arthroscopy and ulnar shortening osteotomy

Interventions

wrist arthroscopy and debridement of Triangular fibrocartilage and shortening of the head ulna by burr

group 1

wrist arthroscopy,debride debridement of Triangular fibrocartilage and shortening of the ulna by osteotomy and plate

group 2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obvious ulnar abutment syndrome with ulnar side wrist pain

You may not qualify if:

  • ulnar minus or neutral variance
  • central and radial wrist pain
  • osteoarthritis of the wrist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Stockton DJ, Pelletier ME, Pike JM. Operative treatment of ulnar impaction syndrome: a systematic review. J Hand Surg Eur Vol. 2015 Jun;40(5):470-6. doi: 10.1177/1753193414541749. Epub 2014 Jul 30.

    PMID: 25080480BACKGROUND
  • Kaufman D, Etcheson J, Yao J. Microfracture for Ulnar Impaction Syndrome: Surgical Technique and Outcomes with Minimum 2-Year Follow-up. J Wrist Surg. 2017 Feb;6(1):60-64. doi: 10.1055/s-0036-1586496. Epub 2016 Aug 5.

    PMID: 28119797BACKGROUND
  • Colantoni J, Chadderdon C, Gaston RG. Arthroscopic wafer procedure for ulnar impaction syndrome. Arthrosc Tech. 2014 Jan 24;3(1):e123-5. doi: 10.1016/j.eats.2013.09.008. eCollection 2014 Feb.

    PMID: 24749031BACKGROUND

MeSH Terms

Interventions

Arthroscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOrthopedic Procedures

Central Study Contacts

Amr El-Sayed Ali

CONTACT

waleed riad saleh

CONTACT

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

May 16, 2017

First Posted

May 30, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share