NCT00786942

Brief Summary

The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 24, 2010

Status Verified

May 1, 2010

Enrollment Period

2 years

First QC Date

November 5, 2008

Last Update Submit

May 21, 2010

Conditions

Osteoarthritis

Keywords

osteotomykneevarus deformitybone graft

Outcome Measures

Primary Outcomes (1)

  • Clinical based bone union time

    after 8 weeks

Secondary Outcomes (1)

  • X-ray femoro-tibial angle

    6 months, 1 year

Study Arms (2)

1

ACTIVE COMPARATOR

autologous bone graft

Procedure: high tibial osteotomy

2

EXPERIMENTAL

without bone graft

Procedure: higi tibial osteotomy

Interventions

high tibial osteotomyPROCEDURE

addition of bone graft to fill the osteotomy gap

Also known as: opening-wedge higi tibial osteotomy
1
higi tibial osteotomyPROCEDURE

the gap of the tibia is unfilled

Also known as: opening-wedge higi tibial osteotomy
2

Eligibility Criteria

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

You may qualify if:

  • varus knee deformity
  • unicompartmental arthrosis

You may not qualify if:

  • patellar arthrosis
  • lateral arthrosis
  • inflammatory diseases
  • bone healing impair drugs or diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Ortopedia do Hospital de Clínicas da Unicamp

Campinas, São Paulo, 13084-971, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Alessandro R Zorzi, MD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • João B Miranda, MD, PhD

    University of Campinas, Brazil

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

April 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2009

Last Updated

May 24, 2010

Record last verified: 2010-05

Locations

BR(1)