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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fitmore short stem<br>Intervention: Total hip arthroplasty with an uncemented femoral short stem, the Fitmore short stem (Zimmer, Warsaw, USA). Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: Fitmore Short Stem | Procedure: Total Hip Arthroplasty<br>* Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.<br>|
| Active Comparator: CLS straight stem<br>Intervention: Total hip arthroplasty with an uncemented femoral straight stem, the CLS short stem (Zimmer, Warsaw, USA).Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: CLS Straight Stem | Procedure: Total Hip Arthroplasty<br>* Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem specific stress shielding of a short compared to a straight hip stem | Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem | Five years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome after short compared to straight stem THA | Clinical outcome measured with the Harris Hip Score and the WOMAC | Five years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DEXA, Total Hip Arthroplasty, Short Stem