Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery
NCT ID: NCT05944679
Last Updated: 2024-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
200 participants
INTERVENTIONAL
2022-01-20
2024-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.
NCT07313449
Questionnaire and Radiography for Prosthesis Follow-up
NCT03745976
ROM Outcomes in Patients Undergoing a Primary TKA
NCT04217486
Radiostereometry in Knee Arthroplasty
NCT04960111
Bone Scintigraphy and Unicompartimental Knee Arthroplasty
NCT03145090
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group Xray
Xray at 1, 3, 6 and 12 months
Xray
Xray at 1, 3, 6 and 12 months after intervention
Group No Xray
Xray at 12 months
No Xray
Just one Xray 12 months after the intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No Xray
Just one Xray 12 months after the intervention
Xray
Xray at 1, 3, 6 and 12 months after intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients awaiting prosthetic knee surgery with a diagnosis of gonarthrosis without age limit (\>18 years)
* All cases of prothesis cemented to the tibia and femur will be included, regardless of whether or not the patellar component is prosthetic
* Patients with knee prothesis and cruciate ligament retention, with ultracongruent polyethylene or posterostabilized as a maximum degree of prosthetic constriction
* The implants will be the usual ones used in our Center for primary prosthetic knee surgery, Journey (smith-Nephew) and Persona or NexGen (Zimmer)
Exclusion Criteria
* Patients undergoing primary prosthetic surgery in relation to tibial plate fractures
* Patients awaiting a unicompartimental or patellofemoral prothesis
* Patients who, for any reason, want to leave the study during the follow-up period
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corporacion Parc Tauli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xavier Pelfort Lopez
Doctor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Parc taulí
Sabadell, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Evans JT, Walker RW, Evans JP, Blom AW, Sayers A, Whitehouse MR. How long does a knee replacement last? A systematic review and meta-analysis of case series and national registry reports with more than 15 years of follow-up. Lancet. 2019 Feb 16;393(10172):655-663. doi: 10.1016/S0140-6736(18)32531-5. Epub 2019 Feb 14.
Gomez-Valero S, Garcia-Perez F, Florez-Garcia MT, Miangolarra-Page JC. A systematic review of self-administered questionnaires for the functional assessment of patients with knee disabilities adapted into Spanish. Rev Esp Cir Ortop Traumatol. 2017 Mar-Apr;61(2):96-103. doi: 10.1016/j.recot.2016.11.002. Epub 2017 Jan 31. English, Spanish.
Walker LC, Clement ND, Bardgett M, Weir D, Holland J, Gerrand C, Deehan DJ. The WOMAC score can be reliably used to classify patient satisfaction after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2018 Nov;26(11):3333-3341. doi: 10.1007/s00167-018-4879-5. Epub 2018 Feb 26.
Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003 May 25;1:17. doi: 10.1186/1477-7525-1-17.
Meneghini RM, Mont MA, Backstein DB, Bourne RB, Dennis DA, Scuderi GR. Development of a Modern Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty. J Arthroplasty. 2015 Dec;30(12):2311-4. doi: 10.1016/j.arth.2015.05.049. Epub 2015 May 29.
Rissolio L, Sabatini L, Risitano S, Bistolfi A, Galluzzo U, Masse A, Indelli PF. Is It the Surgeon, the Patient, or the Device? A Comprehensive Clinical and Radiological Evaluation of Factors Influencing Patient Satisfaction in 648 Total Knee Arthroplasties. J Clin Med. 2021 Jun 12;10(12):2599. doi: 10.3390/jcm10122599.
Sarmah SS, Patel S, Hossain FS, Haddad FS. The radiological assessment of total and unicompartmental knee replacements. J Bone Joint Surg Br. 2012 Oct;94(10):1321-9. doi: 10.1302/0301-620X.94B10.29411.
Ewald FC. The Knee Society total knee arthroplasty roentgenographic evaluation and scoring system. Clin Orthop Relat Res. 1989 Nov;(248):9-12.
Khalifa AA, Mullaji AB, Mostafa AM, Farouk OA. A Protocol to Systematic Radiographic Assessment of Primary Total Knee Arthroplasty. Orthop Res Rev. 2021 Jul 17;13:95-106. doi: 10.2147/ORR.S320372. eCollection 2021.
Baek JH, Lee SC, Choi K, Ahn HS, Nam CH. Long-term survivorship of total knee arthroplasty with a single-radius, high-flexion posterior stabilized prosthesis. Knee. 2021 Jun;30:275-282. doi: 10.1016/j.knee.2021.04.017. Epub 2021 May 11.
Miralles-Munoz FA, Rubio-Morales M, Bello-Tejada L, Gonzalez-Parreno S, Lizaur-Utrilla A, Alonso-Montero C. Varus alignment of the tibial component up to seven degrees is not associated with poor long-term outcomes in a neutrally aligned total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2022 Aug;30(8):2768-2775. doi: 10.1007/s00167-021-06627-3. Epub 2021 Jun 26.
Sabatini L, Aprato A, Camazzola D, Bistolfi A, Capella M, Masse A. Primary total knee arthroplasty in tibial plateau fractures: Literature review and our institutional experience. Injury. 2023 Mar;54 Suppl 1:S15-S23. doi: 10.1016/j.injury.2021.02.006. Epub 2021 Feb 7.
Webb JI, Stoner RS, Afzal I, Evans CR, Scott G, Field RE. The Medial Rotation Knee replacement: Clinical and radiological results of a multi-centre surveillance study at five years. Knee. 2021 Jan;28:247-255. doi: 10.1016/j.knee.2020.12.025. Epub 2021 Jan 13.
Glaser D, Lotke P. Cost-effectiveness of immediate postoperative radiographs after uncomplicated total knee arthroplasty: a retrospective and prospective study of 750 patients. J Arthroplasty. 2000 Jun;15(4):475-8. doi: 10.1054/arth.2000.4338.
Hassan S, Wall A, Ayyaswamy B, Rogers S, Mills SP, Charalambous CP. Is there a need for early post-operative x-rays in primary total knee replacements? Experience of a centre in the UK. Ann R Coll Surg Engl. 2012 Apr;94(3):199-200. doi: 10.1308/003588412X13171221501780.
Novack TA, Patel JN, Koss J, Mazzei C, Harrington CJ, Wittig JC, Dundon J. Is There a Need for Recovery Room Radiographs Following Uncomplicated Primary Total Knee Arthroplasty? Cureus. 2021 Apr 18;13(4):e14544. doi: 10.7759/cureus.14544.
Aljawder A, Alomran D, Alayyoub M, Alkhalifa F. Immediate Postoperative Portable Radiograph After Total Knee Replacements: A Necessity or a Burden? Open Orthop J. 2018 May 31;12:173-179. doi: 10.2174/1874325001812010173. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Radioprotesi
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.