Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
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ClinicalTrials.gov Identifier: NCT01764984 |
Recruitment Status
:
Completed
First Posted
: January 10, 2013
Last Update Posted
: February 4, 2015
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Condition or disease | Intervention/treatment | Phase |
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Unilateral Primary Osteoarthritis of Knee | Device: Total knee arthroplasty | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls. |
Study Start Date : | November 2005 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Trabecular metal
Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate.
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Device: Total knee arthroplasty
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Other Names:
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Active Comparator: Titanium
Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate
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Device: Total knee arthroplasty
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
Other Names:
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- 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.
- 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.
- 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.
- 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.
- SF-36 score [ Time Frame: Pre-operative, 12,24,60 months ]Standardized General health evaluation and quality of life measuring instrument.

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Ages Eligible for Study: | 55 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764984
Canada, Quebec | |
Hôpital Maisonneuve Rosemont | |
Montreal, Quebec, Canada, H1T 2M4 | |
Hopital du Sacre-Coeur | |
Montreal, Quebec, Canada | |
Centre Hospitalier Universitaire de Québec | |
Quebec city, Quebec, Canada, G1R 2J6 |
Principal Investigator: | Etienne L Belzile, MD | Centre Hospitalier Universitaire de Quebec - Universite Laval |
Responsible Party: | Étienne Belzile, Principal Investigator; Orthopaedic surgeon, Centre Hospitalier Universitaire de Québec, CHU de Québec |
ClinicalTrials.gov Identifier: | NCT01764984 History of Changes |
Other Study ID Numbers: |
5.5.04.12 |
First Posted: | January 10, 2013 Key Record Dates |
Last Update Posted: | February 4, 2015 |
Last Verified: | February 2015 |
Keywords provided by Étienne Belzile, Centre Hospitalier Universitaire de Québec, CHU de Québec:
total knee arthroplasty trabecular metal bone mineral density |
Additional relevant MeSH terms:
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |