Changes in Physical Activity, Sleep and Knee Function After Same-Day Discharge Knee Arthroplasty
ConditionArthrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 80
SponsorTurku University Hospital
About this trial
The goal of this observational study is to examine changes in physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes before and after same-day discharge knee arthroplasty (SDD-KA). The study will also investigate whether these changes are associated with each other and with patient satisfaction. As a prespecified secondary aim, researchers will compare these outcomes between patients undergoing medial unicompartmental knee arthroplasty (UKA) and total knee arthroplasty (TKA).
The main questions it aims to answer are:
* How do physical activity, sleep quality, knee extension and flexion strength, knee range of motion, and patient-reported outcomes change following SDD-KA? * Are changes in these outcomes associated with each other and with patient satisfaction? * Are these outcomes different between patients undergoing medial UKA and TKA?
Participants will:
* Wear an accelerometer to measure physical activity and sleep before surgery, continuously from surgery to 3 months after surgery, and again for 2 weeks at 12 months after surgery * Complete questionnaires about knee function, sleep quality, pain, health-related quality of life, and satisfaction with surgery * Have knee muscle strength and active knee range of motion assessed before and 12 months after surgery * Attend follow-up assessments during the 12-month postoperative period
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Full overnight support by an adult at home after discharge
At most mild, well-controlled, comorbidities (e.g. hypertension, hypothyroidism, epilepsy, asthma)
ASA-class 1-2
Age <80 years
Disqualifiers
Post-traumatic osteoarthritis
Neurological disorder aVecting walking or muscle strength
Inability or unwillingness to use a smartphone or to participate in the study
History of cardiac or cerebrovascular events
Trial population
The study population consists of patients undergoing same-day discharge primary knee arthroplasty: medial UKA or TKA according to standard clinical practice at Turku University Hospital. The choice of procedure is made on clinical grounds by the treating surgeon and is not influenced by study participation. Operations are performed by experienced arthroplasty surgeons under spinal anaesthesia following the hospital's standardized same-day discharge protocol.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Medial unicompartmental knee arthroplasty (UKA)
Procedure/SurgeryPrimary medial UKA performed as part of routine clinical care for knee osteoarthritis. The procedure is not assigned by the study.
Total knee arthroplasty (TKA)
Procedure/SurgeryPrimary TKA performed as part of routine clinical care for knee osteoarthritis. The procedure is not assigned by the study.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Medial unicompartmental knee arthroplasty (UKA)1 intervention
Group B: Total Knee Arthroplasty (TKA)1 intervention
Trial outcomes
Primary outcomes
1
Oxford Knee Score (OKS)
A 12-item patient-reported questionnaire assessing knee pain and function during daily activities. Each item is scored from 0 to 4, giving a total score ranging from 0 to 48. Higher scores indicate better knee function and less pain.
Time frame
The OKS will be completed by participants at baseline before surgery and at 3 and 12 months after surgery. The primary outcome is the change in OKS from baseline to 12 months after surgery.Secondary outcomes
1
Objectively measured physical activity (sensor)
Physical activity will be assessed objectively using a wearable accelerometer worn by participants during daily life. The accelerometer will continuously record movement during the predefined measurement periods. Physical activity will be characterized using accelerometer-derived measures of activity, including time spent at different levels of physical activity and daily activity patterns.
Time frame
Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.2
Objectively measured sleep (sensor)
Sleep will be assessed objectively using a wearable accelerometer worn by participants during daily life. Sleep-related measures will be derived from accelerometer recordings during the predefined measurement periods. Sleep measures will be used to characterize changes in sleep patterns.
Time frame
Measurements will be performed during a two-week period before surgery, continuously from surgery to 3 months postoperatively, and during a further two-week period at 12 months after surgery.3
Isometric knee extension and flexion strength
Isometric knee extension and flexion strength will be assessed using a standardized strength measurement procedure. Participants will perform a maximal voluntary isometric knee extension and flexion contraction, and the maximal force produced will be recorded. Higher values indicate greater knee muscle strength.
Time frame
Measurements will be performed before surgery and at 12 months after surgery.4
Knee range of motion
Active knee range of motion will be assessed by measuring knee flexion and extension using a standardized clinical measurement procedure. Knee range of motion will be recorded in degrees. Greater knee flexion and less limitation in knee extension indicate better knee mobility.
Time frame
Measurements will be performed before surgery and at 12 months after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
UKK Institute
Collaborator
Source ClinicalTrials.gov