This trial is active, not recruiting.

Condition knee osteoarthritis
Sponsor University of Milan
Start date June 2013
End date December 2016
Trial size 40 participants
Trial identifier NCT01971931, BioBone01


Bone quality is an important factor influencing the outcome of total knee replacement (TKR) surgery. Therefore, assessing bone quality preoperatively could help the surgeon in the choice of the most appropriate prosthetic implant.

The primary goal of this study is to measure serum and tissue levels of some proteins involved in bone remodelling.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Change in biomarkers serum level after surgery
time frame: One day before surgery; 3 months after surgery and 12 months after surgery

Secondary Outcomes

Change in periprosthetic bone density after surgery
time frame: 3, 6, 12 months after surgery
Biomarkers mRNA expression
time frame: Baseline

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Age > 40, <80 - Indication for TKR - Surgical indication for PFC Sigma®, posterior stabilized, mobile bearing TKR - Patients signed written informed consent Exclusion Criteria: - Age > 80, < 40 - TKR revision surgery - Fixed knee deformities greater than 15° in varus, valgus, flexion or tibial slope. - Knee ankylosis - Paget's disease - Hyperparathyroidism - Patient treated with: bisphosphonates, strontium ranelate, selective estrogen receptor modulators for osteoporosis, calcitonin, denosumab. - Informed consent not accepted - Serious comorbidity - Active infections - Pregnant or breastfeeding women

Additional Information

Official title Prospective Evaluation of Biomarkers Variability in Knee Prosthetic Surgery
Principal investigator Emanuela Galliera, PhD
Description Aseptic implant loosening after TKR causes knee pain, reduces knee function and may require revision surgery. Several proteins have been identified, which are involved in bone metabolism and remodelling; variations in serum levels of some of these proteins after TKR loosening have also been described. However, preoperative identification of risk factors for aseptic loosening remains a challenge. An observational study is conducted to evaluate how levels of the following serum biomarkers vary after TKR: - osteoprotegerin (OPG) - receptor activator of nuclear factor kappa-B (RANK) - receptor activator of nuclear factor kappa-B ligand (RANK-L) - sclerostin - cathepsin K To avoid bias caused by inflammatory states, C reactive protein (CRP), interleukin 1 (IL-1), interleukin 6 (IL-6), tumor necrosis factor α (TNF-α) levels and erythrocyte sedimentation rate (ESR) will be measured. Secondary goals are to evaluate the mRNA expression of OPG, RANK-L, cathepsin K and sclerostin on tibial bone biopsies and to study if changes in serum biomarkers levels after surgery are associated with: - clinical outcomes - periprosthetic bone density - variation of two bone reabsorption markers, the postoperative change of which has already been described in details: type 1 collagen cross-linked C-terminal telopeptide (CTP1) and type 1 procollagen N-terminal telopeptide (P1NP). One day before surgery, after having signed informed consent, patients will undergo a vertebral and femoral dual-energy X-ray absorptiometry (DEXA) scan and blood samples will be collected. During surgery a tibial biopsy will be collected. Between 4 and 7 days postoperatively and 3, 6 and 12 months after surgery patients will again undergo periprosthetic DEXA scans and blood samples will be collected.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Milan.