Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22408
Enrollment
80
Registered
2005-09-15
Start date
2005-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

a prospective randomized trial

Interventions

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

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients (male and female) with symptomatic medial osteoarthritis of the knee who are not indicated for a knee arthroplasty are included.

Exclusion criteria

Exclusion criteria: Exclusion criteria are below 18 years of age, symptoms not related to medial osteoarthritis of the knee or not able to speak or understand Dutch. Patients will be included after informed consent given and baseline measurements made.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)donor site complication (only Group autogenous bone graft).

Contacts

Public ContactT.M. Raaij, van

Erasmus University Medical Center, Department of Orthopaedic Surgery, P.O. Box 2040

t.vanraaij@chello.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)