Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
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
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
|Official title||Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study|
|Principal investigator||John Clohisy, MD|
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