NCT03147131

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

December 19, 2016

Last Update Submit

May 14, 2017

Conditions

Osteoarthritis, Hip

Keywords

Total Hip ArthroplastyShort StemDEXA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical Outcome after short compared to straight stem THA

    Five years postoperatively

Study Arms (2)

Fitmore short stem

ACTIVE COMPARATOR

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

CLS straight stem

ACTIVE COMPARATOR

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

Interventions

Total Hip ArthroplastyPROCEDURE

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

CLS straight stemFitmore short stem

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary or secondary osteoarthritis of the hip
  • written informed consent
  • indication for cementless total hip arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 26613788BACKGROUND

  • 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.

    PMID: 33132094DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Ralf Bieger, PD Dr.

    University Hospital Ulm - Department of Orthopedic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. med

Study Record Dates

First Submitted

December 19, 2016

First Posted

May 10, 2017

Study Start

August 1, 2010

Primary Completion

February 1, 2012

Study Completion

July 1, 2017

Last Updated

May 16, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.