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UnknownNCT03147131

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

Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem: Five-Year Results Of A Prospective, Randomized DEXA-Analysis

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
126 (estimated)
Sponsor
University Hospital Ulm · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
PROCEDURETotal Hip ArthroplastyTotal hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.

Timeline

Start date
2010-08-01
Primary completion
2012-02-01
Completion
2017-07-01
First posted
2017-05-10
Last updated
2017-05-16

Source: ClinicalTrials.gov record NCT03147131. Inclusion in this directory is not an endorsement.