Condition category
Musculoskeletal Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr T M van Raaij

ORCID ID

Contact details

Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands
t.vanraaij@chello.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1; NTR478

Study information

Scientific title

Acronym

Study hypothesis

Opening wedge HTO treated with DBM will better match one year post-operative mechanical axis alignment with pre-operative planned correction than opening wedge HTO filled with autogenous iliac crest bone.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised active controlled factorial trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Arthritis, osteoarthritis

Intervention

A valgus high tibia opening wedge osteotomy will be performed and the osseous defect will be filled with DBM or autogenous bone graft.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Conservation of corrected angular limb deformity one year after surgery (success rate [%]), (surgery is successful when the femoral-tibial axis one year after osteotomy is corrected accurately two degrees or less compared to the preoperative planned mechanical axis correction).

Secondary outcome measures

1. Knee range of motion (ROM)
2. Pain score (Visual Analogue Scale)
3. Hospital for Special Surgery (HHS) Knee Service Rating System
4. Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
5. Health related quality-of-life score (EuroQol)
6. Donor site complication (only autogenous bone graft group)

Overall trial start date

01/10/2005

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female
2. Symptomatic medial osteoarthritis of the knee
3. Not indicated for a knee arthroplasty
4. Informed consent given
5. Baseline measurements are made

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Below 18 years of age
2. Symptoms not related to medial osteoarthritis of the knee
3. Not able to speak or understand Dutch

Recruitment start date

01/10/2005

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus University Medical Centre
Rotterdam
3000 CB
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Dr. Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/content/englishindex.htm

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes