Prospective Evaluation of Biomarkers Variability in Knee Prosthetic Surgery

NCT01971931 | Completed

• 1 other identifier: BioBone01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in biomarkers serum level after surgery

  OPG, RANK, RANK-L, sclerostin, cathepsin K, CTP1 and P1NP levels will be assessed on blood samples. CRP, IL-1, IL-6, TNF-α and ESR will also be measured to identify inflammatory states.

  One day before surgery; 3 months after surgery and 12 months after surgery

Secondary Outcomes (2)

• Change in periprosthetic bone density after surgery

  3, 6, 12 months after surgery

• Biomarkers mRNA expression

  Baseline

Other Outcomes (2)

• Change in knee function score after surgery

  One day before surgery; 3, 6, 12 months after surgery

• Change in knee pain scale after surgery

  One day before surgery; 3, 6, 12 months after surgery

Study Arms (1)

Patients undergoing TKR.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing TKR surgery.

You may qualify if:

• Age \> 40, \<80
• Indication for TKR
• Surgical indication for PFC Sigma®, posterior stabilized, mobile bearing TKR
• Patients signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Policlinico San Donato (Istituto di Ricovero e Cura a Carattere Scientifico)

San Donato Milanese, Milano, 20097, Italy

Location

Related Publications (13)

• Vega D, Maalouf NM, Sakhaee K. CLINICAL Review #: the role of receptor activator of nuclear factor-kappaB (RANK)/RANK ligand/osteoprotegerin: clinical implications. J Clin Endocrinol Metab. 2007 Dec;92(12):4514-21. doi: 10.1210/jc.2007-0646. Epub 2007 Sep 25.

  PMID: 17895323 BACKGROUND

• Colombini A, Lombardi G, Galliera E, Dogliotti G, Randelli P, Meerssemann A, Mineo G, Cabitza P, Corsi MM. Plasma and drainage fluid levels of soluble receptor activator of nuclear factor-kB (sRANK), soluble receptor activator of nuclear factor-kB ligand (sRANKL) and osteoprotegerin (OPG) during proximal humerus fracture healing. Int Orthop. 2011 May;35(5):777-82. doi: 10.1007/s00264-010-1088-3. Epub 2010 Jul 11.

  PMID: 20623281 BACKGROUND

• Rogers A, Eastell R. Circulating osteoprotegerin and receptor activator for nuclear factor kappaB ligand: clinical utility in metabolic bone disease assessment. J Clin Endocrinol Metab. 2005 Nov;90(11):6323-31. doi: 10.1210/jc.2005-0794. Epub 2005 Aug 16.

  PMID: 16105967 BACKGROUND

• Ryd L, Albrektsson BE, Carlsson L, Dansgard F, Herberts P, Lindstrand A, Regner L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83.

  PMID: 7744919 BACKGROUND

• Li MG, Thorsen K, Nilsson KG. Increased bone turnover as reflected by biochemical markers in patients with potentially unstable fixation of the tibial component. Arch Orthop Trauma Surg. 2004 Jul;124(6):404-9. doi: 10.1007/s00402-004-0695-0. Epub 2004 May 20.

  PMID: 15156331 BACKGROUND

• Li MG, Nilsson KG. The effect of the preoperative bone quality on the fixation of the tibial component in total knee arthroplasty. J Arthroplasty. 2000 Sep;15(6):744-53. doi: 10.1054/arth.2000.6617.

  PMID: 11021450 BACKGROUND

• Mertens MT, Singh JA. Biomarkers in arthroplasty: a systematic review. Open Orthop J. 2011 Mar 16;5:92-105. doi: 10.2174/1874325001105010092.

  PMID: 21584201 BACKGROUND

• Kenanidis EI, Potoupnis ME, Papavasillioul KA, Sayegh FE, Petsatodis GE, Kapetanos GA. Serum levels of bone turnover markers following total joint arthroplasty. J Orthop Surg (Hong Kong). 2010 Dec;18(3):290-5. doi: 10.1177/230949901001800307.

  PMID: 21187538 BACKGROUND

• Pijls BG, Valstar ER, Nouta KA, Plevier JW, Fiocco M, Middeldorp S, Nelissen RG. Early migration of tibial components is associated with late revision: a systematic review and meta-analysis of 21,000 knee arthroplasties. Acta Orthop. 2012 Dec;83(6):614-24. doi: 10.3109/17453674.2012.747052. Epub 2012 Nov 9.

  PMID: 23140091 BACKGROUND

• van Loon CJ, Oyen WJ, de Waal Malefijt MC, Verdonschot N. Distal femoral bone mineral density after total knee arthroplasty: a comparison with general bone mineral density. Arch Orthop Trauma Surg. 2001 May;121(5):282-5. doi: 10.1007/s004020000232.

  PMID: 11409560 BACKGROUND

• Minoda Y, Ikebuchi M, Kobayashi A, Iwaki H, Inori F, Nakamura H. A cemented mobile-bearing total knee replacement prevents periprosthetic loss of bone mineral density around the femoral component: a matched cohort study. J Bone Joint Surg Br. 2010 Jun;92(6):794-8. doi: 10.1302/0301-620X.92B6.23159.

  PMID: 20513875 BACKGROUND

• Soininvaara TA, Harju KA, Miettinen HJ, Kroger HP. Periprosthetic bone mineral density changes after unicondylar knee arthroplasty. Knee. 2013 Mar;20(2):120-7. doi: 10.1016/j.knee.2012.10.004. Epub 2012 Nov 13.

  PMID: 23154036 BACKGROUND

• Cucchi D, Menon A, Galliera E, Messina C, Zanini B, Marazzi MG, Massaccesi L, Compagnoni R, Corsi Romanelli MM, Randelli P. A Prospective Assessment of Periprosthetic Bone Mineral Density and Osteoimmunological Biomarkers Variations After Total Knee Replacement Surgery. J Clin Densitom. 2019 Jan-Mar;22(1):86-95. doi: 10.1016/j.jocd.2018.05.039. Epub 2018 May 26.

  PMID: 30072203 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, tibial bone biopsy.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Emanuela Galliera, PhD

  Istituto Ortopedico Galeazzi IRCCS, Milano, Italy

  PRINCIPAL INVESTIGATOR

• Randelli Pietro, MD

  Policlinico San Donato IRCCS, San Donato Milanese, Italy

  STUDY DIRECTOR

• Corsi Romanelli M. Massimiliano, MD

  Policlinico San Donato IRCCS, San Donato Milanese, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 5, 2013
• First Posted: October 30, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)