Records View

Use of autogenous onlay bone graft for tibial bone defects in primary total knee arthroplasty

Status Approved

  • First Submitted Date

    2017/04/14

  • Registered Date

    2017/05/15

  • Last Updated Date

    2017/05/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002328
    Unique Protocol ID 2016-11-001
    Public/Brief Title Use of autogenous onlay bone graft for tibial bone defects in primary total knee arthroplasty
    Scientific Title Use of autogenous onlay bone graft for tibial bone defects in primary total knee arthroplasty
    Acronym AOBG, autogenous onlay bone graft
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number BOHUN 2016-11-001
    Approval Date 2016-11-28
    Institutional Review Board Name Veterans Health Service Medical Center IRB
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Young-Soo Shin
    Title M.D.
    Telephone +82-2-2225-7788
    Affiliation VHS Medical Center
    Address Department of Orthopedic Surgery, Veterans Health Service Medical Center, 61 Jinhwangdoro-gil, Gangdong-Gu, Seoul, Korea (ROK) 134-791
    Contact Person for Public Queries
    Name Young-Soo Shin
    Title M.D.
    Telephone +82-2-2225-7788
    Affiliation VHS Medical Center
    Address Department of Orthopedic Surgery, Veterans Health Service Medical Center, 61 Jinhwangdoro-gil, Gangdong-Gu, Seoul, Korea (ROK) 134-791
    Contact Person for Updating Information
    Name Young-Soo Shin
    Title M.D.
    Telephone +82-2-2225-7788
    Affiliation VHS Medical Center
    Address Department of Orthopedic Surgery, Veterans Health Service Medical Center, 61 Jinhwangdoro-gil, Gangdong-Gu, Seoul, Korea (ROK) 134-791
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2016-11-28 Actual
    Target Number of Participant 19
    Primary Completion Date 2017-03-01 , Actual
    Study Completion Date 2017-03-01 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study VHS Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2016-11-28 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name VHS Medical Center
    Organization Type Medical Institute
    Project ID 2016-11-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name VHS Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: The use of autogenous bone graft is a well–known technique for reconstruction of tibial bone defects in primary total knee arthroplasty (TKA). In cases where the size of the bone graft is inappropriate, the stability of bone graft fixation and subsequent bone graft to host bone incorporation may be compromised. We describe a simple and reliable technique of reconstruction in a proximal tibia bone defect at the time of primary TKA by using autogenous onlay bone graft (AOBG).
    Methods: Records were reviewed of 19 patients (mean age, 72.3 years) who underwent primary TKA using AOBG without the additional cost of allogenous bone or metal augments, between August 2013 and August 2014.
    Results: Mean Knee Society score (KSS) in the 22 knees was significantly higher postoperatively than preoperatively (92 ± 4 vs. 30 ± 7, P<0.001). The mean range of motion (ROM) in the 22 knees, which was 106 ± 12° preoperatively, improved to 112 ± 10° at last follow-up, but this this difference was not significant (P=0.32). No migration of implants and presence of radiolucent lines at the bone cement-prosthesis interface were observed. Furthermore, the serial radiographs of 19 patients not requiring a secondary surgery had a mean time of 3.2 months (range, 2.7 – 4.4 months) for autograft incorporation with cross trabeculation between the proximal tibial bone and graft.
    Conclusions: This simple AOBG supplement technique may biologically promote graft to host bone healing by enhancing fixation stability without the additional cost and fixatives and  assist the surgeon in managing the varying nature of uncontained bone defects, thereby preventing the risk of disease transmission in primary TKA if this surgical technique is accurately performed.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Non-RCT
    Intervention Type /Procedure/Surgery  
    Intervention Description
    Between August 2013 and August 2014, 19 patients (22 knees) were performed primary TKA using AOBG without the additional cost of allogenous bone or metal augments. The present study included 19 patients (10 women and 9 men) with a hip-knee-ankle (HKA) angle of 20˚ or more as measured on preoperative long-standing anteroposterior radiographs. The diagnosis was degenerative osteoarthritis in all cases. The average patient age was 72.3 years  (range, 57 – 85 years) at the time of surgery. At follow-up evaluation, the patients were assessed clinically using Knee Society score (KSS) and range of motion (ROM). Postoperative radiographs and computed tomography (CT) scanning were analyzed for the presence of implant migration, defined as a vertical or angular displacement of the implant by 3 mm or 3°, respectively, and presence of radiolucent lines of ≥1 mm running parallel to the implant margins at the bone cement-prosthesis interface.
    Number of Arms 1
    Arm 1

    Arm Label

    Records were reviewed of 19 patients (mean age, 72.3 years) who underwent primary TKA using AOBG without the additional cost of allogenous bone or metal augments, between August 2013 and August 2014.

    Target Number of Participant

    19

    Arm Type

    Others

    Arm Description

    Between August 2013 and August 2014, 19 patients (22 knees) were performed primary TKA using AOBG without the additional cost of allogenous bone or metal augments. The present study included 19 patients (10 women and 9 men) with a hip-knee-ankle (HKA) angle of 20˚ or more as measured on preoperative long-standing anteroposterior radiographs. The diagnosis was degenerative osteoarthritis in all cases. The average patient age was 72.3 years  (range, 57 – 85 years) at the time of surgery. At follow-up evaluation, the patients were assessed clinically using Knee Society score (KSS) and range of motion (ROM). Postoperative radiographs and computed tomography (CT) scanning were analyzed for the presence of implant migration, defined as a vertical or angular displacement of the implant by 3 mm or 3°, respectively, and presence of radiolucent lines of ≥1 mm running parallel to the implant margins at the bone cement-prosthesis interface.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M17.9)Gonarthrosis, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    57Year~85Year

    Description

    The present study included 19 patients (10 women and 9 men) with a hip-knee-ankle (HKA) angle of 20˚or more as measured on preoperative long-standing anteroposterior radiographs. The  diagnosis was degenerative osteoarthritis in all cases.
    Exclusion Criteria
    Not applicable
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    At follow-up evaluation, the patients were assessed clinically using Knee Society score (KSS) and range of motion (ROM). Postoperative radiographs and computed tomography (CT) scanning were analyzed for the presence of implant migration, defined as a vertical or angular displacement of the implant by 3 mm or 3°, respectively,[1] and presence of radiolucent lines of ≥1 mm running parallel to the implant margins at the bone cement-prosthesis interface. There can be variation of scroring by two different doctors.
    Timepoint
    3 months
    Secondary Outcome(s) 1
    Outcome
     clinical appearance : range of motion (ROM), Radiograph : computed tomography (CT)
    Timepoint
    3 months
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동