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Evaluation of Stability of Two Uncemented Hip Implants Used for Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02656771
Recruitment Status : Active, not recruiting
First Posted : January 15, 2016
Last Update Posted : January 8, 2018
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Zimmer Biomet
Information provided by (Responsible Party):
Karen Dyreborg, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to measure quantitatively the implant stability and implant related remodeling of the periprosthetic femoral bone of the new uncemented Echo® Bi-Metric® Full proximal Profile total hip arthroplasty (THA) stem, and compare it to the classical uncemented Bi-Metric® Porous Primary THA stem by measuring migration of the stem assessed by model-based radiosteriometric analysis (MB-RSA) and measuring the periprosthetic adaptive bone remodeling assessed by dual-energy x-ray absorptiometry (DXA).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Echo Bi-Metric Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Uncemented Echo Bi-Metric Full Proximal Profile THA Stem Versus Uncemented Bi-Metric Porous Primary THA Stem in a Randomized Controlled Trial Using RSA and DXA
Study Start Date : January 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Echo Bi-Metric THA stem

Uncemented titanium alloy press-fit stem with a proximal plasma spray porous titanium coating designed for bone ingrowth and the distal part of the stem has a roughened titanium surface for bone on-growth.

It is a relatively new implant that is now in routine clinical use. The stem uses many of the features of the known and used Integral® and Bi-Metric® hip stems while integrating new design features to further enhance clinical performance such as a reduced neck geometry to allow for increased ROM and decreased risk of neck impingement, a polished neck designed to reduce debris should impingement occur and a polished bullet-shape distal tip to reduce distal stresses.

Device: Echo Bi-Metric
The insertion of the Echo® Bi-Metric® THA stem

No Intervention: Bi-Metric Porous Primary THA stem

Uncemented titanium alloy press-fit stem with a proximal plasma spray porous titanium coating designed for bone ingrowth and the distal part of the stem has a roughened titanium surface for bone on-growth.

It was introduced in 1984 and have shown good clinical results and excellent stem survival in register studies




Primary Outcome Measures :
  1. Migration of the stem [ Time Frame: 2 years ]
    The differences between the two stem designs are evaluated by measurements of migration of the stem assesed by Radiosteriometric analysis (RSA)


Secondary Outcome Measures :
  1. Adaptive bone remodeling [ Time Frame: 2 years ]
    The differences of the two stems are evaluated by measurements of the adaptive bone remodeling of the periprostetic area (femur) assesed by dual energy X-ray absorptiometry (DXA)

  2. Hip function [ Time Frame: 2 years ]
    Hip function postoperatively assesed by Harris Hip Score and Oxford Hip Score



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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients bound to undergo total hip arthroplasty at the Department of Orthopedic - Surgery, Gentofte Hospital, Denmark.
  • Patients who have consented in writing to participate after having understood what it entails.
  • Patients diagnosed with primary osteoarthritis of one or both hips.

Exclusion Criteria:

  • Infection including osteomyelitis and sepsis.
  • Exclusion as a result of technical shortcomings such as poor image quality, estimated by the investigator.
  • Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.).
  • Uncooperative patient or patients with neurological disorders who are considered incapable of following directions.
  • Patients with alcohol or drug abuse, estimated by the investigators.
  • Patients considered unable to understand the information in patients-papers, or who do not want to participate in the study.
  • Patients who do not speak nor understand Danish.
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656771


Locations
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Denmark
Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Zimmer Biomet
Investigators
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Study Chair: Michael M Petersen, Professor Rigshospitalet, Denmark

Publications:

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Responsible Party: Karen Dyreborg, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02656771     History of Changes
Other Study ID Numbers: THA1-KD-14
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018

Keywords provided by Karen Dyreborg, Rigshospitalet, Denmark:
THA
Hip
arthroplasties

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents