Clinical trial NCT05944679: Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery
Official title: Prospective Randomized Study of the Clinical Utility to Follow-up Radiographs During the First Year of Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthetic Knee Surgery
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: KSS Test change
timeFrame: Preoperative, 6 and 12 months
measure: KOOS Test change
timeFrame: Preoperative, 6 and 12 months
measure: SF-12 Test change
timeFrame: Preoperative, 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Parc taulí
state: Barcelona
Study officials:
References:
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