The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive Bone Remodeling in Uncemented Total Knee Arthroplasty (Vanguard Versus Regenerex)
NCT ID: NCT01936415
Last Updated: 2013-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2010-05-31
2013-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
One of the implants (Vanguard) has been used for routine clinical use abroad, but also in Denmark for some years, and so far the results have been good.
The other type coating (Regenerex) is a micro-casting of the structure of normal trabecular bone, but made from metal alloy, in the element Titanium. Titanium is also very biocompatible (Hoffman 1993, Hahn, H 1970) and have been used with great success in e.g. uncemented total hip arthroplasy for several years (Marshall et al. 2004, Meding et al, 2004).
Trabecular metal has a porosious structure close to that of normal trabecular bone, and the biomechanical characteristics such as e.g. compressive strength and elastic modulus are very close to that of normal trabecular bone (Krygier et al. 1999, Zardiackas 2001). These characteristics are the reason why trabecular metal within the past decade have been used for production of different orthopedic implants, and the early clinical results so far have been very promising (Bobyn et al. 2004, Nasser \& Poggie 2004, Nehma et al. 2004, Nelson et al. 2003).
Quantitative measurements of the implant migration and adaptive bone remodeling of the bone close to the implants are generally accepted as suitable methods for an objective evaluation of the effect of joint replacement surgery and have been proposed as mandatory important examinations that must bee performed before new implants are distributed for wide-spread use (Bobyn et al. 2004, Petersen \& Schrøder 2004, Østgaard \& Nielsen 2004).
Very small movements between an implant and the bone can be measured by special RSA X-rays after implantation of small (0.8-1.0 mm) Tantalum markers attached to the implant and in the bone (Selvik 1989), while changes in bone mineral or bone mineral density (BMD) of the bone in close relation to the implant can be measured by DEXA (Glüer et al. 1990, Mazess \& Barden 1988).
Micromovements with migration of the tibial component are seen after both cemented and uncemented TKA during the first postoperative year. Subsequently most implants stabilize, while a minority migrate continuously beyond the first postoperative year (Ryd et al. 1995). The implants that continues to migrate are those with a high risk of later aseptic loosening. Several studies have evaluated the influence of different parameters such as mode of fixation (cemented/uncemented), surface coating e.g. hydroxyapatite, metal alloys, and design of the prostheses on the migration of the tibial component in primary TKA (Ryd 1986), but whether the use of a surface coating of trabecular metal (Titanium) will result in significant differences has not yet been evaluated.
In studies using different bone densitometric techniques for measurements of changes in bone mineral of the proximal tibia after primary TKA a significant decrease in BMD is seen in most studies (Hvid et al. 1988, Karbowski et al. 1999, Levitz et al. 1995, Petersen et al. 1995, Regnér et al. 1999). In some of the studies the decrease in BMD reaches 20% - 36% (Hvid et al. 1988, Levitz et al. 1995, Petersen et al. 1995, Regnér et al. 1999), however, in other studies BMD remains unchaged (Bohr \& Lund 1987, Li \& Nilsson 2000, Spittlehouse et al. 1999) or shows a minor increase (Petersen et al. 2005).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Regenerex
One of the two prosthesis investegated
Regenerex
Vanguard
Vanguard
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vanguard
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
Regenerex
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age between 18 and 70 years.
Exclusion Criteria
2. Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.
3. Premenopausal women.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zimmer Biomet
INDUSTRY
Hillerod Hospital, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nikolaj Winther
Pricipal Incestigatior. MD, Consultant in Orthopeadic.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1. Knee Unit Hørsholm, Department of Orthopaedic Surgery, Hillerød Hospital, Denmark
Hillerød, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-3-2009-077
Identifier Type: -
Identifier Source: org_study_id