Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Total Hip Arthroplasty | Total 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.