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

NCT ID: NCT03147131

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-01

Study Completion Date

2017-07-31

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).

Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Fitmore short stem

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

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

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

CLS straight stem

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

Group Type ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type PROCEDURE

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

Interventions

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Total Hip Arthroplasty

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ulm

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. med Ralf Bieger

PD Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ralf Bieger, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm - Department of Orthopedic Surgery

References

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Freitag T, Hein MA, Wernerus D, Reichel H, Bieger R. Bone remodelling after femoral short stem implantation in total hip arthroplasty: 1-year results from a randomized DEXA study. Arch Orthop Trauma Surg. 2016 Jan;136(1):125-30. doi: 10.1007/s00402-015-2370-z. Epub 2015 Nov 27.

Reference Type BACKGROUND
PMID: 26613788 (View on PubMed)

Meyer JS, Freitag T, Reichel H, Bieger R. Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem. Orthop Traumatol Surg Res. 2020 Dec;106(8):1495-1500. doi: 10.1016/j.otsr.2020.04.023. Epub 2020 Oct 31.

Reference Type DERIVED
PMID: 33132094 (View on PubMed)

Other Identifiers

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D.3067-244/10

Identifier Type: -

Identifier Source: org_study_id

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