NCT01122017

Brief Summary

The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
Last Updated

May 13, 2010

Status Verified

April 1, 2010

Enrollment Period

2.1 years

First QC Date

December 1, 2009

Last Update Submit

May 12, 2010

Conditions

Outcome Measures

Primary Outcomes (2)

  • The proportion of patellar length (in mm)to the patellar tendon length (in mm)

    The length of the patella (in its longest diameter on a lateral x-ray) to the length of the patellar tendon is referred as Insall-Salvati index

    up to 13 months

  • The proportion of patellar articular surface length (in mm)to the patella-tibial plateau distance (in mm)

    The length of the articular surface of the patella to the distance from the patella to the tibial plateau is referred as Blackburne-Peel index.

    up to 13 months

Secondary Outcomes (2)

  • Quadriceps angle in degree

    up to 13 months

  • Inclination of proximal tibial plateau in degree

    up to 13 months

Study Arms (1)

Medial Opening-Wedge Osteotomy

EXPERIMENTAL

Medial Opening-Wedge Osteotomy (MOWO) is an approach for the correction of malalignment of the knee

Procedure: Retro-Tubercle Opening-Wedge High Tibial Osteotomy

Interventions

Retro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee.

Medial Opening-Wedge Osteotomy

Eligibility Criteria

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

You may qualify if:

  • symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury

You may not qualify if:

  • fractures through compartments of the knee or the patella
  • osteoarthritis other than in the medial compartment
  • degrees or more extension lag
  • tibial malrotation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Beheshti University of Medical Sciences

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Genu Varum

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Mohammad Reza Abbasian, Dr.

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2009

First Posted

May 12, 2010

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

November 1, 2008

Last Updated

May 13, 2010

Record last verified: 2010-04

Locations