Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery

NCT05944679 | Completed

• 1 other identifier: Radioprotesi
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Primary prosthetic surgery for the treatment of gonarthrosis is currently one of the most prevalent surgical treatments in Traumatology. The Arthroplasty Register in Catalonia, which started in 2005, counted more than 60.000 knee prothesis until 2015. Regarding the peridiocity for taking control radiographs in patients undergoing knee replacement surgery, there is no consensus. This means, that in similar studies that evaluate the results of prosthetic surgery, there is a great variability in radiological follow-up protocols, especifically during the firts post-operative years. Given the high prevalence and the long survival period demonstrated by these implants, it seems reasonable to be able to establish the real value of the radiographs performed during the first year of follow-up after surgery. From this perspective, the aim of our study is to evaluate if conducting just two radiographs instead of five during the first postoperative year after the surgery, has any influence on the clinical and functional results of our patients.

Conditions

Prosthetic Knee Surgery

Outcome Measures

Primary Outcomes (3)

• KSS Test change

  Change value from preoperative condition to 12 months after operation, including 6 month assessment

  Preoperative, 6 and 12 months

• KOOS Test change

  Change value from preoperative condition to 12 months after operation, including 6 month assessment

  Preoperative, 6 and 12 months

• SF-12 Test change

  Change value from preoperative condition to 12 months after operation, including 6 month assessment

  Preoperative, 6 and 12 months

Study Arms (2)

Group Xray

PLACEBO COMPARATOR

Xray at 1, 3, 6 and 12 months

Radiation: Xray

Group No Xray

ACTIVE COMPARATOR

Xray at 12 months

Radiation: No Xray

Interventions

No Xray RADIATION

Just one Xray 12 months after the intervention

Group No Xray

Xray RADIATION

Xray at 1, 3, 6 and 12 months after intervention

Group Xray

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who voluntarily agree to be part of the study and sign the informed consent
• 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)

You may not qualify if:

• Patients who do not voluntariily agree to participate
• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Parc taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (17)

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  PMID: 34204628 BACKGROUND

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  PMID: 2805502 BACKGROUND

• 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.

  PMID: 34305412 BACKGROUND

• 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.

  PMID: 33984746 BACKGROUND

• 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.

  PMID: 34175990 BACKGROUND

• 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.

  PMID: 33583591 BACKGROUND

• 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.

  PMID: 33453513 BACKGROUND

• 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.

  PMID: 10884208 BACKGROUND

• 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.

  PMID: 22507727 BACKGROUND

• 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.

  PMID: 34017659 BACKGROUND

• 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.

  PMID: 29997704 BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 13, 2023
• Study Start: January 20, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)