Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Osteoarthritis of Hip Clinical Trial

Official title:

Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957970
• Other study ID #: 2009-7-17
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2009
• Last updated: August 12, 2009
• Start date: July 2006
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis of Hip
• Osteoarthritis, Hip

Intervention

Device:
• Stemless femoral component
Total hip femoral component anatomically designed for a proximal fit without a stem
• IPS, Depuy cementless femoral stem
Anatomical proximal fitted cementless stemmed femoral component

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. German. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density of surrounding proximal femur according to Gruen zones		At least 2years after surgery	No
Secondary	Harris hip score		2 years	No