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criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2017/04/14
    • Registered Date : 2017/05/15
    • Last Updated Date : 2017/05/10
Background Information
1.Background  
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
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
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  
Status
4. Status Status  
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 Site VHS Medical Center 
- Recruitment Status Completed  
- Date of First Enrollment 2016-11-28 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name VHS Medical Center 
- Organization Type Medical Institute  
- Project ID 2016-11-001 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name VHS Medical Center 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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
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. 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 57 Year ~ 85 Year
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No