Clinical trial NCT02000297: Outcome Comparison of Allograft and Synthetic Bone Substitute in High Tibial Osteotomy
Official title: Outcome Comparison of Allogenic Cancellous Bone and a New Synthetic Bone Substitute (geneX®) in Filling the Bone Defect Created With Medial Open Wedge High Tibial Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis
Knee
High tibial osteotomy
Calcium phosphate
Calcium sulfate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Temporal change of postoperative pain
timeFrame: from 2 days after surgery to 12 months after surgery
Secondary outcomes:
measure: Pre&postoperative Hemoglobin level
timeFrame: on admission (preop.), postoperative day 2 (postop.)
measure: Total operation time
timeFrame: from skin incision to deflation of tourniquet
measure: Temporal change of weight bearing status
timeFrame: from 2 weeks after surgery to 12 months after surgery
measure: Temporal change of pain with weight bearing
timeFrame: from 2 weeks after surgery to 12 months after surgery
measure: Amount of drainage
timeFrame: from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2
measure: Working time for bone defect filling
timeFrame: from the start of processing allograft or synthetic bone substitute to finish filling bone defect
measure: Temporal progression of bone healing on X-rays
timeFrame: from 3 months after surgery to 12months after surgery
Other outcomes:
measure: Amount of transfusion
timeFrame: from the start of operation until discharge of the patient from hospital (which is anticipated on postoperative day 2 on average)
measure: Postoperative complications
timeFrame: from the date of operation to the date of occurence of any complications, assessed up to 12 months after surgery
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Joint Reconstruction Center, Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Joint Reconstruction Center, Seoul National University Bundang Hospital
name: Tae Kyun Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: