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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03147131
Enrollment
126
Registered
2017-05-10
Start date
2010-08-01
Completion date
2017-07-31
Last updated
2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Keywords

Total Hip Arthroplasty, Short Stem, DEXA

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).

Interventions

PROCEDURETotal Hip Arthroplasty

Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.

Sponsors

University Hospital Ulm
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stem specific stress shielding of a short compared to a straight hip stemFive years postoperativelyPeriprosthetic Bone Mineral Density changes around a total hip arthroplasty stem

Secondary

MeasureTime frameDescription
Clinical Outcome after short compared to straight stem THAFive years postoperativelyClinical outcome measured with the Harris Hip Score and the WOMAC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026