- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000297
Outcome Comparison of Allograft and Synthetic Bone Substitute in High Tibial Osteotomy
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Seongnam-Si, Gyeonggi-do, Korea, Republic of, 463-707
- Recruiting
- Joint Reconstruction Center, Seoul National University Bundang Hospital
-
Contact:
- Tae Kyun Kim, MD, PhD
- Phone Number: 82-31-787-7196
- Email: osktk@snubh.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy
|
Experimental: 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
|
Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Temporal change of postoperative pain
Time Frame: from 2 days after surgery to 12 months after surgery
|
Pain on operation site is measured on a 0-to-10 visual analogue scale(VAS) and 5-point Likert scale (0.no pain, 1.slight pain, 2.moderate pain, 3.severe pain, 4.extreme pain). Initial postoperative pain will be recorded on postoperative day 2. After discharge from hospital (on postoperative day 2, on average), patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and pain measurements on each visit will be recorded. |
from 2 days after surgery to 12 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pre&postoperative Hemoglobin level
Time Frame: on admission (preop.), postoperative day 2 (postop.)
|
Preoperative hemoglobin level is measured when the patient is admitted to the hospital for surgery and postoperative level is measured on postoperative day 2. The differences between values will be calculated.
|
on admission (preop.), postoperative day 2 (postop.)
|
Total operation time
Time Frame: from skin incision to deflation of tourniquet
|
Total operation time is defined as the time interval between skin incision and deflation of tourniquet (thigh tourniquet used in the operation to provide bloodless surgical field).
Measured in minutes.
|
from skin incision to deflation of tourniquet
|
Temporal change of weight bearing status
Time Frame: from 2 weeks after surgery to 12 months after surgery
|
As a proxy variable of bone healing status, whether the patient can bear weight on operated knee is measured on a 3 point scale (1.full weight bearing, 2.partial weight bearing, 3.no weight bearing) Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and weight bearing status on each visit will be recorded. |
from 2 weeks after surgery to 12 months after surgery
|
Temporal change of pain with weight bearing
Time Frame: from 2 weeks after surgery to 12 months after surgery
|
As a proxy variable of bone healing status, pain with weight bearing is measured on a 0-to-10 visual analogue scale(VAS) and 5-point Likert scale (0.no pain, 1.slight pain, 2.moderate pain, 3.severe pain, 4.extreme pain) Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and pain with weight bearing on each visit will be recorded. |
from 2 weeks after surgery to 12 months after surgery
|
Amount of drainage
Time Frame: from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2
|
Total amount of drainage (in milliliters) from indwelling drain located in operative site, until its removal.
|
from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2
|
Working time for bone defect filling
Time Frame: from the start of processing allograft or synthetic bone substitute to finish filling bone defect
|
Time required to fill the bone defect (from the start of processing either allogenic bone graft or synthetic bone substitute to completely finish filling the defect.
Measured in seconds.
|
from the start of processing allograft or synthetic bone substitute to finish filling bone defect
|
Temporal progression of bone healing on X-rays
Time Frame: from 3 months after surgery to 12months after surgery
|
Two independent investigators assess the progression of bone healing status on X-rays and the agreement between investigators will be measured. Bone healing status is assessed based on 3 point scale. (1. union not achieved yet, 2. partial union achieved, 3. complete union achieved) Patients will visit outpatient department on 2weeks, 6weeks, 3months, 6months, 12months after surgery and bone healing status on X-rays will be recorded on 3months, 6months and 12months after surgery. |
from 3 months after surgery to 12months after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of transfusion
Time Frame: from the start of operation until discharge of the patient from hospital (which is anticipated on postoperative day 2 on average)
|
Amount of transfusion during patient's hospital stay, if any, is measured in packs.
|
from the start of operation until discharge of the patient from hospital (which is anticipated on postoperative day 2 on average)
|
Postoperative complications
Time Frame: from the date of operation to the date of occurence of any complications, assessed up to 12 months after surgery
|
When an event of postoperative complication occurs, it is recorded with postoperative date.
|
from the date of operation to the date of occurence of any complications, assessed up to 12 months after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tae Kyun Kim, MD, PhD, Joint Reconstruction Center, Seoul National University Bundang Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1309/220-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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