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

NCT03970460 | Unknown

• 1 other identifier: PTG-Young
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• DEXA Scan

  This exam will quantify the amount of bone density at 24 months after total knee arthroplasty. DXA scan can provide accurate, high-quality measurements of periprosthetic bone mineral density (BMD) with minimal precision error and a low coeficient of variation ranging from 1.3% to 4.7%17.

  24 months post-op

• KOOS (knee injury and osteoarthritis outcomes score )

  The Index is self-administered and assesses the 5 subscales: pain (9 questions), other symptoms (7 questions), function in daily living (17 questions), function in sports and recreation (5) and knee related quality of live (4). All subscales are on 100, 100 being the best score, 0 the worst. The total score is an average of all subscale

  2 years post-op

• KSS (Knee Society Score)

  The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.

  2 years post-op

Secondary Outcomes (2)

• The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2)

  2 years post-op

• Lyshom and Tegner

  2 years post-op

Study Arms (4)

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

ACTIVE COMPARATOR

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

Device: Primary TKA with cemented modular metal-backed tibial implant

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

ACTIVE COMPARATOR

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

Device: Primary TKA with cemented modular metal-backed tibial implant

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

EXPERIMENTAL

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

Device: Primary TKA with uncemented trabecular metal

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

EXPERIMENTAL

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

Device: Primary TKA with uncemented trabecular metal

Interventions

Primary TKA with cemented modular metal-backed tibial implant DEVICE

Tibial implant will be done with a cemented implant

45-54 y.o / cemented modular metal-backed tibial implant; 55-59 y.o / cemented modular metal-backed tibial implant

Primary TKA with uncemented trabecular metal DEVICE

Tibial implant will be done with a uncemented implant

45-54 y.o / uncemented Trabecular Metal modular tibial implant; 55-59 y.o / uncemented Trabecular Metal modular tibial implant

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• Zimmer Biomet: collaborator
• CHU de Québec: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michel Malo, ND

  Hôpital Sacré-Coeur de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 31, 2019
• Study Start: August 5, 2011
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: February 18, 2020

Record last verified: 2020-02