A Comparison of the Design of Tibia Stems in Cemented Total Knee Arthroplasty - Wedge Stem Versus I-beam Stem.
1 other identifier
interventional
54
1 country
1
Brief Summary
The purpose of this study is to compare the early migration and periprosthetic bone changes of two cemented total knee arthroplasties with different tibial stem design. Only the tibial prostheses plateau varies in that one is an wedge-shaped stem and the other is a I-shaped stem.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 10, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJanuary 4, 2023
October 1, 2010
4.8 years
September 10, 2005
January 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tibial component migration evaluated by RSA.
post-operative, three months, six months, one year, two years
Periprosthetic bone changes evaluated by DEXA.
post-operative, one year, two years
Secondary Outcomes (1)
Micromotion of the modular polyethylene liner in both type prostheses evaluated by RSA.
post-operative, three months, six months, one year, two years
Study Arms (2)
I-beam
ACTIVE COMPARATORI-beam stem design of tibial component for Total Knee Arthroplasty.
wedge
ACTIVE COMPARATORWedge stem design of tibial component for Total Knee Arthroplasty.
Interventions
Operation with Total Knee Arthroplasty and either an I-beam stem or a wedge stem of the tibial component.
Eligibility Criteria
You may qualify if:
- Patients with one- or double-sided primary knee arthrosis.
- Patients with a sufficient bone quality for implantation of knee prosthesis.
- Informed and written patient consent.
You may not qualify if:
- Patients with neuromuscular or vascular diseases in the affected leg.
- Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
- Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
- Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporosis.
- Patients with knee arthrosis following fracture sequelae.
- Women, who are pregnant or are at risk of getting pregnant throughout the 2 year follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Orthopaedic Center, Aarhus University Hospital
Aarhus, 8000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kjeld Søballe, MD, Prof.
Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2005
First Posted
September 15, 2005
Study Start
January 1, 2005
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
January 4, 2023
Record last verified: 2010-10