Demineralised bone matrix (DBM) as an alternative for autogenous bone graft in high tibial valgus opening wedge osteotomy (HTO) for symptomatic medial compartmental knee osteoarthritis

ISRCTN	ISRCTN76261748
DOI	https://doi.org/10.1186/ISRCTN76261748
Protocol serial number	1; NTR478
Sponsor	Erasmus Medical Centre (The Netherlands)
Funder	Not provided at time of registration

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr T M van Raaij
Scientific

Erasmus University Medical Centre
Department of Orthopaedic Surgery
P.O. Box 2040
Rotterdam
3000 CB
Netherlands

Email	t.vanraaij@chello.nl

Primary study design	Interventional
Study design	Multicentre, randomised active controlled factorial trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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)
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/10/2005
Date of final enrolment	31/12/2007

Erasmus University Medical Centre

Rotterdam
3000 CB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan