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)

NCT01637051 | Active Not Recruiting DMC

• 1 other identifier: H-1-2012-033
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Arthrosis of the Knee

Outcome Measures

Primary Outcomes (1)

• migration of tibial component

  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).

  three years

Secondary Outcomes (1)

• Knee function

  three years

Study Arms (2)

Zimmer NexGen®, Trabecular Metal Technology (TMT) Monoblock

OTHER

The tibial component has a monoblock design

Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock

Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

OTHER

The tibial component has a modular design

Device: Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

Interventions

Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock DEVICE

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) Monoblock

Zimmer NexGen® Trabecular Metal Technology (TMT), Modular DEVICE

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Zimmer Biomet: collaborator

Study Sites (2)

Gentofte Hospital

Copenhagen, Denmak, 2900, Denmark

Location

Gentofte Hospital

Copenhagen, 2900, Denmark

Location

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Study Officials

• Mikkel Rathsach Andersen, Ph.D

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Læge, Ph.D

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

DK (2)