Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem

Not Applicable

• Conditions: Osteoarthritis, Hip

• Registration Number: NCT03147131
• Lead Sponsor: University Hospital Ulm

Brief Summary

The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.

Detailed Description

After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).

Study Timeline

• Study Start: 2010-08-01
• Primary Completion: 2012-02
• Study First Submitted: 2016-12-19
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-10
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Primary or secondary osteoarthritis of the hip
• written informed consent
• indication for cementless total hip arthroplasty

Exclusion Criteria

• previous surgery in the same hip
• femoral fracture
• metabolic bone disease
• drugs affecting bone quality
• contralateral THA within the study period
• infectious disease or bony tumor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stem specific stress shielding of a short compared to a straight hip stem	Five years postoperatively	Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem

Secondary Outcome Measures

Name	Time	Method
Clinical Outcome after short compared to straight stem THA	Five years postoperatively	Clinical outcome measured with the Harris Hip Score and the WOMAC