NCT02000297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

November 11, 2013

Last Update Submit

October 13, 2014

Conditions

Osteoarthritis, Knee

Keywords

OsteoarthritisKneeHigh tibial osteotomyCalcium phosphateCalcium sulfate

Outcome Measures

Primary Outcomes (1)

  • Temporal change of postoperative pain

    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 Outcomes (7)

  • Pre&postoperative Hemoglobin level

    on admission (preop.), postoperative day 2 (postop.)

  • Total operation time

    from skin incision to deflation of tourniquet

  • Temporal change of weight bearing status

    from 2 weeks after surgery to 12 months after surgery

  • Temporal change of pain with weight bearing

    from 2 weeks after surgery to 12 months after surgery

  • Amount of drainage

    from the end of surgery until drain removal, which is anticipated on postoperative day 1 or 2

  • +2 more secondary outcomes

Other Outcomes (2)

  • Amount of transfusion

    from the start of operation until discharge of the patient from hospital (which is anticipated on postoperative day 2 on average)

  • Postoperative complications

    from the date of operation to the date of occurence of any complications, assessed up to 12 months after surgery

Study Arms (2)

Allogenic bone graft group

ACTIVE COMPARATOR

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

Procedure: Allogenic bone graft

Synthetic bone substitute (geneX®) group

EXPERIMENTAL

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

Procedure: Synthetic bone substitute (geneX®)

Interventions

Allogenic bone graftPROCEDURE

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

Allogenic bone graft group
Synthetic bone substitute (geneX®)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

Synthetic bone substitute (geneX®) group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Tae Kyun Kim, MD, PhD

    Joint Reconstruction Center, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae Kyun Kim, MD, PhD

CONTACT

82-31-787-7196osktk@snubh.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Direcor, Joint reconstruction center, SNUBH

Study Record Dates

First Submitted

November 11, 2013

First Posted

December 4, 2013

Study Start

October 1, 2013

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

KR(1)