This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.
Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery. 2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at three (3) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at six (6) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Quality of Life (WOMAC)
Time frame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Quality of life (SF-36)
Time frame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Kidney function
Creatinine clearance
Time frame: Before surgery and at three, six and twelve months after surgery
Liver function
ALT, AST
Time frame: Before surgery and at three, six and twelve months after surgery
Bone turnover markers
Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Time frame: At three, six and twelve months after surgery
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