The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive Bone Remodeling in Uncemented Total Knee Arthroplasty (Vanguard Versus Regenerex)

NCT01936415 | Completed Phase 4

• 1 other identifier: H-3-2009-077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In a prospective randomised study two uncemented tibial components with different coating (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component coatings are designed to provide excellent conditions 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

Artrosis of the Knee

Keywords

Knee prosthesis

Outcome Measures

Primary Outcomes (1)

• Migration of the tibial component

  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). The differens is messured in millimeters.

  three years

Study Arms (2)

Regenerex

EXPERIMENTAL

One of the two prosthesis investegated

Device: Regenerex

Vanguard

ACTIVE COMPARATOR

Device: Vanguard

Interventions

Vanguard DEVICE

A prospective randomized study where the patients are randomized to receive one of two prostheses (tibial components) with different coating: Vanguard pourous coating, Biomet and Regenerex® Primary Tibial Tray, Biomet. Both prostheses are available and approved by the FDA. The main difference between the implants is the coating of the tibial tray

Vanguard

Regenerex DEVICE

Regenerex

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe osteoarthrosis of the knee with indication for a TKA.
• Age between 18 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.
• Premenopausal women.

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Zimmer Biomet: collaborator

Study Sites (1)

1. Knee Unit Hørsholm, Department of Orthopaedic Surgery, Hillerød Hospital, Denmark

Hillerød, 3400, Denmark

Location

Related Publications (1)

• Winther NS, Jensen CL, Jensen CM, Lind T, Schroder HM, Flivik G, Petersen MM. Comparison of a novel porous titanium construct (Regenerex(R)) to a well proven porous coated tibial surface in cementless total knee arthroplasty - A prospective randomized RSA study with two-year follow-up. Knee. 2016 Dec;23(6):1002-1011. doi: 10.1016/j.knee.2016.09.010. Epub 2016 Oct 19.

  PMID: 27769563 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pricipal Incestigatior. MD, Consultant in Orthopeadic.

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: September 6, 2013
• Study Start: May 1, 2010
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

DK (1)