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
CRIS Registration Number |
KCT0002328 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | VHS Medical Center |
Organization Type | Medical Institute |
Project ID | 2016-11-001 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | VHS Medical Center |
Organization Type | Medical Institute |
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M17.9)Gonarthrosis, unspecified |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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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. |
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Timepoint | 3 months |
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Secondary Outcome(s) 1 | ||
Outcome | clinical appearance : range of motion (ROM), Radiograph : computed tomography (CT) |
|
Timepoint | 3 months |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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