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

NCT02000297 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-10-15

No results posted yet for this study

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.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

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

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Tae Kyun Kim, MD, PhD · Joint Reconstruction Center, Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000297 on ClinicalTrials.gov