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

Primary Purpose

Osteoarthritis, Hip

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
University Hospital Ulm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Total Hip Arthroplasty, Short Stem, DEXA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Fitmore short stem

    CLS straight stem

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Stem specific stress shielding of a short compared to a straight hip stem
    Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem

    Secondary Outcome Measures

    Clinical Outcome after short compared to straight stem THA
    Clinical outcome measured with the Harris Hip Score and the WOMAC

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    May 14, 2017
    Sponsor
    University Hospital Ulm
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03147131
    Brief Title
    Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2010 (Actual)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    July 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital Ulm

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Hip
    Keywords
    Total Hip Arthroplasty, Short Stem, DEXA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fitmore short stem
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    CLS straight stem
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Total Hip Arthroplasty
    Intervention Description
    Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.
    Primary Outcome Measure Information:
    Title
    Stem specific stress shielding of a short compared to a straight hip stem
    Description
    Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem
    Time Frame
    Five years postoperatively
    Secondary Outcome Measure Information:
    Title
    Clinical Outcome after short compared to straight stem THA
    Description
    Clinical outcome measured with the Harris Hip Score and the WOMAC
    Time Frame
    Five years postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ralf Bieger, PD Dr.
    Organizational Affiliation
    University Hospital Ulm - Department of Orthopedic Surgery
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Individual participant data will not be shared.
    Citations:
    PubMed Identifier
    26613788
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33132094
    Citation
    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.
    Results Reference
    derived

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

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