Overview

This trial is active, not recruiting.

Conditions osteoarthritis, post-traumatic osteoarthritis, rheumatoid arthritis
Treatments cemented tibia, cementless tibia
Phase phase 2/phase 3
Sponsor Washington University School of Medicine
Collaborator Wright Medical Technology
Start date December 2009
End date September 2014
Trial size 250 participants
Trial identifier NCT01041937, Clohisy TKA trial

Summary

The primary purpose of TKA Randomized Clinical Trial- Cemented versus Cementless Tibial Prosthesis Study will determine whether there is a significant difference in patient-reported and measured clinical outcomes (e.g. pain, function, length of recovery, and patient satisfaction) between subjects treated with a cementless tibial prosthesis (the cementless group) and those treated with cemented tibial prosthesis (the cement group) over the first two postoperative years. Radiographs will be assessed before surgery and at established post-operative intervals to determine if there are any significant differences between patients in the two groups and to assess the influence of component fixation on radiographic stability over time. Complication and revision rates will also be assessed for comparison.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Assessing the clinical outcomes of the different type of fixation
cemented tibia
Total knee arthroplasty with cemented or cemented tibia, and post operative clinical outcome tracking
(Active Comparator)
Assessing the clinical outcomes of the different type of fixation
cementless tibia
Assessing the clinical outcomes of the different type of fixation

Primary Outcomes

Measure
To use clinical outcome measures to assess for differences in patient function, quality of life and satisfaction between patients who have tibial component placement with either a cemented or a cementless technique
time frame: 2014

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - BMI less than <35 - Normal neurological function - Primary total knee arthroplasty (Pre operative Medial Knee Patient) - Patient age ≤ 70 years old Exclusion Criteria: - Revision surgery - History of joint sepsis - Recent systemic corticosteroids (< 2 months prior to procedure) - Primary or secondary carcinoma in the last five years - Post operative renal transplant - Psychosocial disorders limiting rehabilitation - Previous intraarticular knee fracture - Over 20° valgus or varus deformity - Extension loss over 20° - Unsuitable for cruciate- substituting arthroplasty - Unsuitable for cementless fixation of the tibial component - Need for augmentation wedges or bone graft - Previous proximal tibial osteotomy

Additional Information

Official title Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study
Principal investigator John Clohisy, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.