Outcome Comparison of Allograft and Synthetic Bone Substitute in High Tibial Osteotomy

NCT ID: NCT02000297

Last Updated: 2014-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-01-31

Brief Summary

This study is conducted to determine whether a new synthetic bone substitute is better than allogenic bone graft for addressing bone defect in medial open wedge high tibial osteotomy in terms of postoperative pain, postoperative bleeding, operation time and bone healing. The investigators hypothesized the new synthetic bone substitute would bring better outcomes in the outcome variables mentioned above.

Detailed Description

High tibial osteotomy is a well-established treatment option for the young patients (aged 40~55years) with knee osteoarthritis which is confined in medial compartment of the knee. Classical technique was lateral closing wedge osteotomy, but recently medial open wedge osteotomy has gained popularity with the advent of new fixation devices and refined surgical techniques. The surgeon can correct the deformity more precisely in both coronal and sagittal planes simultaneously with medial opening technique. And it can avoid complications associated with lateral closing technique like tibial shaft offset or peroneal nerve palsy. But medial opening technique inevitably creates large bone defect, which has to be addressed to avoid complications like loss of correction or delayed/non-union. Autologous bone is widely accepted as a standard for filling bone defects, but its supply is limited and harvesting autologous bone adds to surgical morbidity like bleeding, pain or fracture at the donor site. Therefore, there has been much effort to find materials to substitute autologous bone. Many studies reported the results of using allogenic bone for addressing bone defects and most of them showed favorable results. But some allogenic bone products are cumbersome to process to make it fit to the defect, and there are potential risk of disease transmission, if the products are not properly treated. Bone cements of several different composition has been developed and when used for filling bone defect, they also showed good results in general. Recently, a new synthetic bone substitute based on calcium phosphate and calcium sulfate (geneX®, Biocomposites Co.,Ltd.) has been introduced and is commercially available. While providing initial mechanical strength, its calcium sulfate component is rapidly absorbed to provide space for new bone ingrowth and its surface is made to negatively charged, which helps accelerate new bone formation. It is provided as an injectable paste, which is easier to handle than allogenic bone, so it may help reduce operation time. With these theoretical advantages, there are some anecdotal reports that patients treated with geneX® presented less postoperative pain and bleeding than patients treated with allogenic bone graft. Therefore, we conducted this study to determine whether the new synthetic bone substitute (geneX®) is better than allogenic bone for addressing bone defect created in medial open wedge high tibial osteotomy.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Allogenic bone graft group

Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy

Group Type: ACTIVE_COMPARATOR

Allogenic bone graft

Intervention Type: PROCEDURE

Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy

Synthetic bone substitute (geneX®) group

Patients in this arm is treated with synthetic bone substitute(geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy

Group Type: EXPERIMENTAL

Synthetic bone substitute (geneX®)

Intervention Type: PROCEDURE

Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy

Interventions

Allogenic bone graft

Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy

Intervention Type: PROCEDURE

Synthetic bone substitute (geneX®)

Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of primary osteoarthritis of the knee which is confined to medial compartment
• Scheduled for high tibial osteotomy
• Written signed consent available

Exclusion Criteria

• Patients who refuse to participate in the study
• Previous history of major orthopedic surgery around the operating knee
• Congenital anomaly involving proximal tibia
• Revision high tibial osteotomy
• Patients who is receiving another major knee surgery simultaneously with high tibial osteotomy at the same knee

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae Kyun Kim

Direcor, Joint reconstruction center, SNUBH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tae Kyun Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Joint Reconstruction Center, Seoul National University Bundang Hospital

Locations

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Tae Kyun Kim, MD, PhD

Role: CONTACT

osktk@snubh.org

82-31-787-7196

Facility Contacts

Tae Kyun Kim, MD, PhD

Role: primary

osktk@snubh.org

82-31-787-7196

Other Identifiers

B-1309/220-005

Identifier Type: -

Identifier Source: org_study_id