Total Knee Arthroplasty (TKA) Cemented Versus Cementless Tibial Prosthesis Study
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Arthritis, Osteoarthritis (OA), Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/10/2019 |
| Start Date: | December 2009 |
| End Date: | December 2011 |
Total Knee Arthroplasty Randomized Clinical Trial- Cemented vs. Cementless Tibial Prosthesis Study
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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