Back to resultsBone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Primary Purpose
Osteoarthritis of Hip
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Stemless femoral component
IPS, Depuy cementless femoral stem
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Hip focused on measuring Stress shielding, Bone mineral density, stemless femoral component
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis of hip joint requiring total hip arthroplasty
Exclusion Criteria:
- Neurologic disorders affecting motor function of lower extremity
- foot and ankle disorders limiting ambulation of the patient
- Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
- Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Sites / Locations
- Ewha Womans University Mokdong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Stemless femoral component
Stemmed femoral component
Arm Description
Stemless PROXIMA femoral component
IPS, proximal anatomical fit stemmed femoral component
Outcomes
Primary Outcome Measures
Bone mineral density of surrounding proximal femur according to Gruen zones
Secondary Outcome Measures
Harris hip score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00957970
Brief Title
Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Official Title
Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
Detailed Description
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip
Keywords
Stress shielding, Bone mineral density, stemless femoral component
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stemless femoral component
Arm Type
Active Comparator
Arm Description
Stemless PROXIMA femoral component
Arm Title
Stemmed femoral component
Arm Type
Active Comparator
Arm Description
IPS, proximal anatomical fit stemmed femoral component
Intervention Type
Device
Intervention Name(s)
Stemless femoral component
Other Intervention Name(s)
PROXIMA, DePuy stem,
Intervention Description
Total hip femoral component anatomically designed for a proximal fit without a stem
Intervention Type
Device
Intervention Name(s)
IPS, Depuy cementless femoral stem
Other Intervention Name(s)
IPS, Depuy anatomical proximal fit stemmed femoral component
Intervention Description
Anatomical proximal fitted cementless stemmed femoral component
Primary Outcome Measure Information:
Title
Bone mineral density of surrounding proximal femur according to Gruen zones
Time Frame
At least 2years after surgery
Secondary Outcome Measure Information:
Title
Harris hip score
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis of hip joint requiring total hip arthroplasty
Exclusion Criteria:
Neurologic disorders affecting motor function of lower extremity
foot and ankle disorders limiting ambulation of the patient
Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, MD
Organizational Affiliation
Korean Joint replacement Center
Official's Role
Study Director
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
17377765
Citation
Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.
Results Reference
background
PubMed Identifier
19562565
Citation
Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.
Results Reference
background
PubMed Identifier
18983669
Citation
Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.
Results Reference
background
PubMed Identifier
12375241
Citation
Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.
Results Reference
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Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
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