SPECT-CT metabolic and morphological study of 2 types of cemented hip stem prostheses in primary total hip arthroplasty patients: A protocol for a randomized controlled clinical trial (SPECT-PROTMA).
Journal
Medicine
ISSN: 1536-5964
Titre abrégé: Medicine (Baltimore)
Pays: United States
ID NLM: 2985248R
Informations de publication
Date de publication:
30 Dec 2021
30 Dec 2021
Historique:
received:
29
11
2021
accepted:
29
11
2021
entrez:
30
12
2021
pubmed:
31
12
2021
medline:
15
2
2022
Statut:
ppublish
Résumé
Cemented hip arthroplasty requires applying a layer of polymethylmethacrylate (cement) in the space between the bone and the prosthetic stem. This can be achieved using 2 techniques: the thick-layer technique (requires a layer of at least 2 mm to surround an undersized prosthetic stem), and the thin-layer technique (requires a thin layer of cement, so that the prosthetic stem fills the femoral medullary canal). Both approaches have excellent long-term clinical and radiological outcomes, although an implant's insertion into the bone generates inevitable bone mass and bone metabolic changes around it. Combination of single photon emission computed tomography and computed tomography scan (SPECT-CT) imaging combines the single photon emission computed tomography's ability to provide detailed bone metabolism assessment with the computed tomography scan's capacity to provide a meticulous anatomical study. This is a single center, open label, randomized clinical trial, performed in the premises of the Bellvitge University Hospital. Participants will be randomly assigned to the Thick-layer technique group (Exeter V40 Cemented Femoral Stem) or to the French paradox technique group (Müller Straight Stem). All participants will have a SPECT-CT scan study at 3, 6, 12, and 24 months after the surgery. Surgical distress itself and the implant's insertion into the bone may cause microvascular changes that alter periprosthetic bone mass and bone metabolism. To the best of our knowledge, there are no studies using SPECT-CT to compare bone metabolism evolution in the postoperative period between these 2 surgical cementation techniques. We aim to provide information in this regard that could help decision making in complicated implant cases and, maybe, pave the way for larger, and methodologically improved studies. NCT05010733 (August 18, 2021).
Sections du résumé
BACKGROUND
BACKGROUND
Cemented hip arthroplasty requires applying a layer of polymethylmethacrylate (cement) in the space between the bone and the prosthetic stem. This can be achieved using 2 techniques: the thick-layer technique (requires a layer of at least 2 mm to surround an undersized prosthetic stem), and the thin-layer technique (requires a thin layer of cement, so that the prosthetic stem fills the femoral medullary canal). Both approaches have excellent long-term clinical and radiological outcomes, although an implant's insertion into the bone generates inevitable bone mass and bone metabolic changes around it. Combination of single photon emission computed tomography and computed tomography scan (SPECT-CT) imaging combines the single photon emission computed tomography's ability to provide detailed bone metabolism assessment with the computed tomography scan's capacity to provide a meticulous anatomical study.
METHODS
METHODS
This is a single center, open label, randomized clinical trial, performed in the premises of the Bellvitge University Hospital. Participants will be randomly assigned to the Thick-layer technique group (Exeter V40 Cemented Femoral Stem) or to the French paradox technique group (Müller Straight Stem). All participants will have a SPECT-CT scan study at 3, 6, 12, and 24 months after the surgery.
DISCUSSION
CONCLUSIONS
Surgical distress itself and the implant's insertion into the bone may cause microvascular changes that alter periprosthetic bone mass and bone metabolism. To the best of our knowledge, there are no studies using SPECT-CT to compare bone metabolism evolution in the postoperative period between these 2 surgical cementation techniques. We aim to provide information in this regard that could help decision making in complicated implant cases and, maybe, pave the way for larger, and methodologically improved studies.
TRIAL REGISTRATION
BACKGROUND
NCT05010733 (August 18, 2021).
Identifiants
pubmed: 34967362
doi: 10.1097/MD.0000000000028299
pii: 00005792-202112300-00017
pmc: PMC8718198
doi:
Substances chimiques
Bone Cements
0
Banques de données
ClinicalTrials.gov
['NCT05010733']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e28299Informations de copyright
Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
The authors have no conflicts of interest to disclose.
Références
Holzwarth U, Cotogno G. Total Hip Arthroplasty: State of the Art, Prospects and Challenges. EUR 25378 EN. 2012;Luxembourg (Luxembourg): Publications Office of the European Union, JRC72428, page 3.
Parvizi J, Klatt BA. Essentials in Total Hip Arthroplasty. 2013;Thorofare, NJ: Slack, page 140.
El Masri F, Kerboull L, Kerboull M, Courpied JP, Hamadouche M. Is the so-called ‘French paradox’ a reality? J Bone Joint Surg 2010;92-B:342–8.
Venesmaa P, Vanninen E, Miettinen H, Kröger H. Periprosthetic bone turnover after primary total hip arthroplasty measured by single-photon emission computed tomography. Scand J Surg 2012;101:241–8.
Tam HH, Bhaludin B, Rahman F, Weller A, Ejindu V, Parthipun A. SPECT-CT in total hip arthroplasty. Clin Radiol 2014;69:82–95.
Yendo al Hospital. I. Diagnóstico por imagen: Radiodiagnóstico y Medicina Nuclear. SEPR. [cited July 7, 2021]. Available at: https://www.sepr.es/profesionales/descargables/download/82-area-medica/4070-yendo-al-hospital-i-diagnostico-por-imagen-radiodiagnostico-y-medicina-nuclear . Accessed July 7, 2021.
Brix G, Nekolla EA, Borowski M, Noßke D. Radiation risk and protection of patients in clinical SPECT-CT. Eur J Nucl Med Mol Imaging 2013;41(S1):125–36.
Van den Wyngaert T, Strobel K, Kampen WU, et al. The EANM practice guidelines for bone scintigraphy. Eur J Nucl Med Mol Imaging 2016;43:1723–38.
Son HJ, Jeong YJ, Yoon HJ, et al. Visual pattern and serial quantitation of 18F-sodium fluoride PET/CT in asymptomatic patients after hip and knee arthroplasty. Nucl Med Mol Imaging 2016;50:308–21.
Mushtaq N, To K, Gooding C, Khan W. Radiological imaging evaluation of the failing total hip replacement. Front Surg 2019;6:35.
Harris WH, McCarthy JC, OʼNeill DA. Femoral component loosening using contemporary techniques of femoral cement fixation. J Bone Joint Surg 1982;64:1063–7.
Øvre S, Sandvik L, Madsen JE, Røise O. Comparison of distribution, agreement and correlation between the original and modified Merle d’Aubigné-Postel Score and the Harris Hip Score after acetabular fracture treatment: moderate agreement, high ceiling effect and excellent correlation in 450 patients. Acta Orthop 2005;76:796–802.
Harris W. Traumatic arthritis of the hip after dislocation and acetabular fractures. J Bone Joint Surg 1969;51:737–55.
Merle D’Aubigné R. Cotation chiffré de la fonction de la hanche [Numerical classification of the function of the hip. 1970]. Rev Chir Orthop Reparatrice Appar Mot 1990;76:371–4. French.
Roos M, Klässbo LS, Lohmander EM. WOMAC Osteoarthritis Index: reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Scand J Rheumatol 1999;28:210–5.
EuroQol Group. EuroQol–a new facility for the measurement of health-related quality of life. Health Policy (Amsterdam, Netherlands) 1990;16:199–208.
Yamane T, Kuji I, Seto A, Matsunari I. Quantification of osteoblastic activity in epiphyseal growth plates by quantitative bone SPECT-CT. Skeletal Radiol 2018;47:805–10.
Chan A-W, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7.