NCT03291015

Brief Summary

To Compare Between Radiological Guided Treatment And Arthroscopic Guided Treatment Of KIENBOCK Disease

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 Oct 2017

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

September 7, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

September 7, 2017

Last Update Submit

September 19, 2017

Conditions

Kienbock Disease

Keywords

arthroscopyradiographic(plain X ray)

Outcome Measures

Primary Outcomes (1)

  • Comparison Between Radiological Guided Treatment(15Patient) And Arthroscopic Guided Treatment(Other 15Patient) Of KIENBOCK Disease

    it is found tht 70% ofkienbock disease patient treated by radiographic guided treatment plan is not satisfied sothat we will analyse the persentage of satisfied patient treated by arthroscopic guided treatment plan versus radiographic guided treatment plan

    baseline

Study Arms (2)

radiographic guided treatment

OTHER

radiographic guided treatment of kienbock disease using plain x ray for determine treatment plan

Device: radiographic

arthroscopic guided treatment

OTHER

arthroscopic guided treatment of kienbock disease using wrist arthroscopy for determine treatment plan (Wrist arthroscopy)

Device: arthroscopy

Interventions

radiographicDEVICE

using plain x ray to determind the treatment plan

radiographic guided treatment
arthroscopyDEVICE

using wrist arthroscopy to determind the treatment plan

arthroscopic guided treatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult persons with average age of 20-60 years.
  • Persons coming to outpatient clinic and trauma unit complaining Of Chronic Wrist pain
  • Plain x-ray films Antero-posterior View And lateral views of the Wrist

You may not qualify if:

  • Persons \< 20 years or \> 60 years.
  • Traumatic WristWithFracture
  • Previous Wrist surgery.
  • Patient With Condraindication To plain X-Ray

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Nealey EM, Petscavage-Thomas JM, Chew FS, Allan CH, Ha AS. Radiologic Guide to Surgical Treatment of Kienbock's Disease. Curr Probl Diagn Radiol. 2018 Mar-Apr;47(2):103-109. doi: 10.1067/j.cpradiol.2017.04.012. Epub 2017 Apr 25.

    PMID: 28619441BACKGROUND

  • Lichtman DM, Lesley NE, Simmons SP. The classification and treatment of Kienbock's disease: the state of the art and a look at the future. J Hand Surg Eur Vol. 2010 Sep;35(7):549-54. doi: 10.1177/1753193410374690. Epub 2010 Jul 9.

    PMID: 20621943BACKGROUND

  • Stahl S, Stahl AS, Meisner C, Hentschel PJH, Valina S, Luz O, Schaller HE, Lotter O. Critical analysis of causality between negative ulnar variance and Kienbock disease. Plast Reconstr Surg. 2013 Oct;132(4):899-909. doi: 10.1097/PRS.0b013e31829f4a2c.

    PMID: 24076682BACKGROUND

  • Roth JH, Poehling GG, Whipple TL. Arthroscopic surgery of the wrist. Instr Course Lect. 1988;37:183-94.

    PMID: 3418121BACKGROUND

  • Bain GI, Munt J, Turner PC. New advances in wrist arthroscopy. Arthroscopy. 2008 Mar;24(3):355-67. doi: 10.1016/j.arthro.2007.11.002. Epub 2008 Jan 29.

    PMID: 18308189BACKGROUND

  • Bain GI, Begg M. Arthroscopic assessment and classification of Kienbock's disease. Tech Hand Up Extrem Surg. 2006 Mar;10(1):8-13. doi: 10.1097/00130911-200603000-00003.

    PMID: 16628114BACKGROUND

  • Bain GI, MacLean SB, Tse WL, Ho PC, Lichtman DM. Kienbock Disease and Arthroscopy: Assessment, Classification, and Treatment. J Wrist Surg. 2016 Nov;5(4):255-260. doi: 10.1055/s-0036-1584546. Epub 2016 Jun 20.

    PMID: 27777814BACKGROUND

  • Bain GI, Durrant A. An articular-based approach to Kienbock avascular necrosis of the lunate. Tech Hand Up Extrem Surg. 2011 Mar;15(1):41-7. doi: 10.1097/BTH.0b013e31820e82e8.

    PMID: 21358525BACKGROUND

MeSH Terms

Conditions

Osteonecrosis

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

youssef zaki, resident

CONTACT

01222364028youssefmalak33@yahoo.com

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

September 7, 2017

First Posted

September 25, 2017

Study Start

October 1, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

September 25, 2017

Record last verified: 2017-09