NCT03065738

Brief Summary

Effect Of Reduction Osteotomy On Gap Balancing During Total Knee Replacement For Severe Varus Deformity

Trial Health

43
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 Jan 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 13, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

January 31, 2017

Last Update Submit

March 9, 2017

Conditions

Genu VarumKnee Osteoarthritis

Keywords

reduction osteotomyknee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • HKA angle

    standing A.P radiograph

    immediate post operative

Secondary Outcomes (1)

  • functional outcome by knee society score

    one year follow up

Study Arms (1)

osteoarthritis knee ,severe varus deformity

EXPERIMENTAL

reduction osteotomy in total knee replacement

Other: tibial reduction osteotomy in total knee replacement

Interventions

tibial reduction osteotomy in total knee replacementOTHER

reduction osteotomy :downsizing of tibial tray with lateralization

osteoarthritis knee ,severe varus deformity

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with severe varus deformity more than 15 degrees (long film-mechanical axis)
  • Patients with bone defect of medial tibial condyle

You may not qualify if:

  • Patients with extra-articular deformity
  • Patients with valgus deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University School of medicine Vice Dean for Research and Post-Graduate Studies

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Genu VarumOsteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesOsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Hatem Bakr, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Alaa Safwat, Msc

CONTACT

002-01067655744alaasafwat84@yahoo.com

Yasser Khalifa, MD

CONTACT

002-01006134669Ykhalifa67@hotmail.co

Study Design

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

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 28, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

February 1, 2018

Last Updated

March 13, 2017

Record last verified: 2017-02

Locations

EG(1)