The Importance of Different Modularity of the Polyethylene Insert for Tibial Component Migration and Adaptive Bone Remodeling After Uncemented Total Knee Arthroplasty Using Trabecular Metal Technology (TMT) Zimmer NexGen®, (Monoblock vs. Modular Design)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Mikkel Rathsach Andersen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01637051
First received: July 6, 2012
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

In a prospective randomised study two uncemented tibial components with different polyethylene modularities (Trabecular Metal Technology (TMT) Zimmer NexGen® monobloc and TMT Zimmer NexGen® modular) used for total knee arthroplasty (TKA) is evaluated. Both tibial component coatings are designed to provide excellent condition for bone ingrowth.

The differences between the two tibial components are evaluated by measurements of migration of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry (DEXA).


Condition Intervention
Arthrosis of the Knee
Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock
Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Importance of Different Modularity of the Polyethylene Insert for Tibial Component Migration and Adaptive Bone Remodeling After Uncemented Total Knee Arthroplasty Using Trabecular Metal Technology (TMT) Zimmer NexGen®, (Monoblock vs. Modular Design)

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • migration of tibial component [ Time Frame: three years ] [ Designated as safety issue: Yes ]
    The differences between two tibial components are evaluated by measurements of migration of the tibial component assesed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assesed by dual energy X-ray absorpitiometry (DEXA).


Secondary Outcome Measures:
  • Knee function [ Time Frame: three years ] [ Designated as safety issue: No ]
    knee function postoperativly assessed by Oxford Knee Score


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: August 2025
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Zimmer NexGen®, Trabecular Metal Technology (TMT) Monoblock
The tibial component has a monoblock design
Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock

A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).

The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert.

Zimmer NexGen® Trabecular Metal Technology (TMT), Modular
The tibial component has a modular design
Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).

The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

The participants of the study are patients that have been scheduled for a primary TKA using the usual indications for TKA at the Department of Planned Elective Surgery Z, Gentofte Hospital.

Inclusion Criteria:

  • Severe osteoarthrosis of the knee with indication for a TKA.
  • Age between 40 and 70 years.

Exclusion Criteria:

  • Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.).
  • Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637051

Locations
Denmark
Gentofte Hospital
Copenhagen, Denmak, Denmark, 2900
Gentofte Hospital
Copenhagen, Denmark, 2900
Sponsors and Collaborators
Rigshospitalet, Denmark
Zimmer, Inc.
Investigators
Principal Investigator: Mikkel Rathsach Andersen, Ph.D Rigshospitalet, Denmark
  More Information

Publications:

Responsible Party: Mikkel Rathsach Andersen, Læge, Ph.D, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01637051     History of Changes
Other Study ID Numbers: H-1-2012-033
Study First Received: July 6, 2012
Last Updated: August 28, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014