Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy | NCT00786942

Studies
Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy

NCT00786942

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

May 24, 2010Estimated

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

high tibial osteotomy
higi tibial osteotomy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2009Actual

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2010

Last Update Posted Date

May 24, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	autologous bone graft	Procedure: high tibial osteotomy
2	Experimental	without bone graft	Procedure: higi tibial osteotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high tibial osteotomy	Procedure	addition of bone graft to fill the osteotomy gap	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical based bone union time		after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
X-ray femoro-tibial angle		6 months, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

varus knee deformity
unicompartmental arthrosis

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alessandro R Zorzi, MD	University of Campinas, Brazil	Principal Investigator
João B Miranda, MD, PhD	University of Campinas, Brazil	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departamento de Ortopedia do Hospital de Clínicas da Unicamp		Campinas	São Paulo	13084-971	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided