CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 60 target
Drug / intervention
Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01637051
NCT01637051N/AActiveUpdate OverdueUpdated 50mo ago · Completion was 134mo ago
Enrollment Stalled
CompareCT.gov

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)

Rigshospitalet, Denmark·interventional·Posted Jul 10, 2012·Updated Apr 27, 2022

In Brief

A clinical study evaluating Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock and Zimmer NexGen® Trabecular Metal Technology (TMT), Modular for Arthrosis of the Knee. Active but no longer recruiting, targeting 60 participants across 2 sites.

Signals

Enrollment appears stalled

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthrosis of the Knee
CountriesDenmark
CollaboratorsZimmer Biomet

Timeline

N/AActive
20132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2012
Enrollment StartJul 1, 2012
Primary CompletionMay 1, 2015
Study CompletionAug 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.0 years ago

Interventions

Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblockdevice

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), Modulardevice

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.