Completed

NCT Number: NCT05944679

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

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.

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Key information

Conditions

Prosthetic Knee Surgery

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc taulí

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No Xray

Radiation

Just one Xray 12 months after the intervention

Xray

Radiation

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

Primary outcomes

KSS Test change

Time frame: Preoperative, 6 and 12 months

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

Time frame: Preoperative, 6 and 12 months

Change value from preoperative condition to 12 months after operation, including 6 month assessment
SF-12 Test change

Time frame: Preoperative, 6 and 12 months

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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jul 13, 2023
Registry last updated: Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.