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Completed

NCT Number: NCT01764984

Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty

Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. A recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. The material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. While introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. However, it introduced other modes of failures. Micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. Factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. Studies have described a significant decrease in postoperative Bone mineral density (BMD), adjacent to the implants, after total knee replacement. No study, to our knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial base plate designs. Direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. No randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Sacre-Coeur, Montreal, Quebec, Canada

Loading trial locations.

About this study

Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Tri-compartmental knee arthrosis
  • 55 to 75 years of age
  • Stable health condition

Exclusion criteria

  • Inflammatory arthritis
  • Osteonecrosis
  • Infection
  • Amputation (AK or BK)
  • Biphosphonates
  • Metal in the proximal tibia (25cm)
  • History of fracture or osteotomy
  • Ligament instability

Treatment and study plan

Total knee arthroplasty

Device

Total knee arthroplasty using parapatellar approach and postero-stabilized implants.

Other names: NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer), NexGen Option Stemmed (Titanium) modular tibia (Zimmer).

Primary outcomes

  1. Change in Bone Mineral Density (%) from baseline initial value

    Time frame: post-operative 7 to 10 days, 6,12,24 months

    Evaluation of Bone Mineral Density using dual energy x-ray absorptiometry (DEXA) scan under tibial base plate implant after Total knee arthroplasty.

Secondary outcomes

  1. Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.

    Time frame: Pre-operative, 6,12,24,60 months

    Standardized clinical evaluation instrument specific to Total knee arthroplasty population.

  2. number of study subject with implant loosening

    Time frame: 12, 24, 60 months

    Radiological evaluation of implant loosening according to Radiographic Knee Society Score at follow-up after total knee arthroplasty.

  3. Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.

    Time frame: pre-operative, 6,12,24,60 months

    Standardized clinical outcome instruments specific to total knee arthroplasty population.

  4. SF-36 score

    Time frame: Pre-operative, 12,24,60 months

    Standardized General health evaluation and quality of life measuring instrument.

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.

Important dates

Study start
2005
Primary completion
2009
Study completion
2015
First posted
Jan 10, 2013
Registry last updated
Feb 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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