Denosumab for Treating Periprosthetic Osteolysis. (NCT02299817) | Clinical Trial Compass
UnknownPhase 2
Denosumab for Treating Periprosthetic Osteolysis.
Sweden20 participantsStarted 2015-08
Plain-language summary
The main objective is to study the efficacy of denosumab in reducing wear-induced osteolysis around uncemented acetabular implants used in total hip arthroplasty. Patients included in the study will receive the same dose of 60 mg denosumab or placebo (1 ml solution) for a total of 6 doses with start on day one and every 6 months with last treatment at 30 months. The primary endpoint will be the change in volume of the osteolytic lesion over 3 years measured (measured with 3D-CT in cm³).
Who can participate
Age range40 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 40-85 years
* Short Portable Mental Status Questionnaire (SPMSQ) also named pfeiffers test ≥7
* Male and females
* The primary total hip arthroplasty performed between 7 to 20 years before inclusion.
* The primary total hip arthroplasty performed due to osteoarthritis or congenital dysplasia of the hip.
* Uncemented cup fixation
* Baseline osteolytic lesion of at least 4 cm³ and at most 40 cm³ around an uncemented acetabular component with a polyethylene liner.
* Participant is willing and able to follow study protocol and has provided informed consent prior to any study specific procedures.
Exclusion Criteria:
* For women of childbearing potential: Subject refuses to use 1 highly effective method of contraception (contraceptive pill, intra uterine contraceptive device) for the duration of the study and for 10 months after the last dose of study medication.
* For males with a partner of childbearing potential: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
* For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 10 months after the last dose of study medication.
* Pain in the operated hip (because the presence of hip pain in combination with an osteolytic lesion is an indication for revision surgery). VAS \>3
* Previous revision surgery of the hip i.e. exchange of any inplant after the primary surgery
* Inflammatory ar…