Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

NCT00957970 | Completed Phase 4 DMC

• 1 other identifier: 2009-7-17
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of Hip

Keywords

Stress shielding; Bone mineral density; stemless femoral component

Outcome Measures

Primary Outcomes (1)

• Bone mineral density of surrounding proximal femur according to Gruen zones

  At least 2years after surgery

Secondary Outcomes (1)

• Harris hip score

  2 years

Study Arms (2)

Stemless femoral component

ACTIVE COMPARATOR

Stemless PROXIMA femoral component

Device: Stemless femoral component

Stemmed femoral component

ACTIVE COMPARATOR

IPS, proximal anatomical fit stemmed femoral component

Device: IPS, Depuy cementless femoral stem

Interventions

Stemless femoral component DEVICE

Total hip femoral component anatomically designed for a proximal fit without a stem

Also known as: PROXIMA, DePuy stem,

Stemless femoral component

IPS, Depuy cementless femoral stem DEVICE

Anatomical proximal fitted cementless stemmed femoral component

Also known as: IPS, Depuy anatomical proximal fit stemmed femoral component

Stemmed femoral component

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis of hip joint requiring total hip arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 17377765 BACKGROUND

• 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.

  PMID: 19562565 BACKGROUND

• 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.

  PMID: 18983669 BACKGROUND

• 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.

  PMID: 12375241 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Young-Hoo Kim, MD

  Korean Joint replacement Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: August 13, 2009
• Study Start: July 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2009
• Last Updated: August 13, 2009

Record last verified: 2009-08

Locations

KR (1)