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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05944679
Enrollment
200
Registered
2023-07-13
Start date
2022-01-20
Completion date
2024-05-31
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prosthetic Knee Surgery

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.

Interventions

RADIATIONNo Xray

Just one Xray 12 months after the intervention

RADIATIONXray

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

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
KSS Test changePreoperative, 6 and 12 monthsChange value from preoperative condition to 12 months after operation, including 6 month assessment
KOOS Test changePreoperative, 6 and 12 monthsChange value from preoperative condition to 12 months after operation, including 6 month assessment
SF-12 Test changePreoperative, 6 and 12 monthsChange value from preoperative condition to 12 months after operation, including 6 month assessment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026