Evaluation of Bone Mineral Density Changes Using Two Tibial Base Plate Designs in Primary Total Knee Arthroplasty in Young Patient

NCT ID: NCT03970460

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-05
• Study Completion Date: 2020-12-30

Brief Summary

Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient.

In a previous study submitted for publication, the investigators have looked at BMD in vivo after total knee replacement comparing two different tibial base plate designs in cemented and uncemented implants in terms of stiffness and modularity, and its effect on bone density changes, synovitis, osteolysis or survivorship. The investigators found a difference of 18% in bone mineral density favoring trabecular metal implant over cemented modular metal-back implant in patient between 55 and 75 years of age. The trabecular metal implant thus behaved as it was expected and preserved bone density in an elderly population.

No randomized clinical trial has looked at cemented titanium tibial insert to uncemented trabecular metal tibia insert in young population. In order to isolate stiffness as study variable, one would aim at randomizing a homogeneous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial baseplate, titanium versus trabecular metal. The trabecular metal implant is closer to human bone modulus of elasticity.

Detailed Description

THE GOAL OF OUR STUDY IS TO

1. Quantify the amount of bone remodeling 24 months after total knee arthroplasty using sequential dual-energy x-ray absorptiometry of the proximal tibia in younger and more active patients (less than 60 years of age).

2. Evaluate the evolution of functional outcome over a 24 months period using sequential subjective and objective clinical evaluations using the Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and Sf-12 v2 in this cohort of patients.

3. There is also an interest in looking at the activity level before and after the surgery (by using the Tegner Activity Level Scale and the UCLA Activity Level Scale) and to determine the ability to return to an active lifestyle and the impact on implant survival.

Two groups will be created:

Group 1: NexGen cemented modular metal-backed tibial implant (Titanium) Group 2: NexGen uncemented Trabecular Metal(TM) modular tibial implant A total of 88 patients will be recruited

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

45-54 y.o / cemented modular metal-backed tibial implant

This group will undergo a surgery for a knee arthroplasty following standard procedure at our center

Group Type: ACTIVE_COMPARATOR

Primary TKA with cemented modular metal-backed tibial implant

Intervention Type: DEVICE

Tibial implant will be done with a cemented implant

55-59 y.o / cemented modular metal-backed tibial implant

This group will undergo a surgery for a knee arthroplasty following standard procedure at our center

Group Type: ACTIVE_COMPARATOR

Primary TKA with cemented modular metal-backed tibial implant

Intervention Type: DEVICE

Tibial implant will be done with a cemented implant

45-54 y.o / uncemented Trabecular Metal modular tibial implant

This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant

Group Type: EXPERIMENTAL

Primary TKA with uncemented trabecular metal

Intervention Type: DEVICE

Tibial implant will be done with a uncemented implant

55-59 y.o / uncemented Trabecular Metal modular tibial implant

This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant

Group Type: EXPERIMENTAL

Primary TKA with uncemented trabecular metal

Intervention Type: DEVICE

Tibial implant will be done with a uncemented implant

Interventions

Primary TKA with cemented modular metal-backed tibial implant

Tibial implant will be done with a cemented implant

Intervention Type: DEVICE

Primary TKA with uncemented trabecular metal

Tibial implant will be done with a uncemented implant

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Tricompartmental osteoarthritis of the knee
• Age, under 60 years old at the time of surgery
• Stable health (the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history).

Exclusion Criteria

• Diagnosis of inflammatory joint disease
• Diagnosis of osteonecrosis
• Infection; acute or chronic
• Any current metal hardware on the proximal 25 cm of the tibia
• History, remote or recent, of high tibial osteotomy or tibial plateau fracture
• Any collateral ligamentous instability in the affected knee
• Contra lateral below knee or above knee amputation
• Ongoing Biphosphonate pharmacotherapy
• Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic,respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
• Participants of a study who have received an investigational drug or device within the last 30 days
• Patients unwilling or unable to cooperate in a follow-up program
• Bone deficit (subchondral cyst)
• Previous contralateral Total Knee Arthroplasty (TKA), ORIF, HTO
• Patella deficiency needing grafting or preventing patella resurfacing

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

CHU de Québec

UNKNOWN

Sponsor Role: collaborator

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Michel Malo

Orthopaedic surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Malo, ND

Role: PRINCIPAL_INVESTIGATOR

Hôpital Sacré-Coeur de Montréal

Other Identifiers

PTG-Young

Identifier Type: -

Identifier Source: org_study_id