Wearable Sensors for Monitoring Recovery After Total Knee Arthroplasty
ConditionArthroplasty, Replacement, Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAalborg University Hospital
About this trial
The goal of this observational study is to investigate the potential of wearable sensors for monitoring the postoperative recovery of patients after TKA.
The main question the study aims to answer is:
• whether alterations in gait characteristics and the changes in PA levels measured by wearable PA trackers can accurately reflect a patient's postoperative recovery status and provide clinically relevant information to aid their management.
Participants will wear PA trackers during the perioperative period of TKA (2 weeks before until 3 months after, and then agin for 2 weeks one year after the surgery) and we will analyze their gait and PA and correlate them with their recovery after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with knee OA and scheduled to undergo unilateral TKA at Aalborg University Hospital, Farsø.
Disqualifiers
Daily pain (numeric rating scale (NRS) ≥ 4) or severe OA in the contralateral knee (KL-IV)
Daily pain (NRS ≥ 4) or severe OA in the spine and other lower limb joints
BMI > 35 kg/m2
Recent surgery in the spine or lower limbs (< 6 months)
Trial population
All eligible patients who are scheduled for TKA from a certain date onwards will be screened and offered participation in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Measuring gait
Other interventionMeasurements are performed by PA trackers. The measurements include: * Lower limb 3D linear accelerations according to gait bouts collected and stored as time-series of linear accelerations with a frequency of 12.5 Hz. * Details on the amount of time spent lying down, sitting, and standing, as well as the number of steps and sit-to-stands completed throughout the day. This information will be stored in 15-minute epochs and then summarized into daily summaries for analysis.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The postoperative daily changes from the baseline (preoperative) Fourier coefficients of walking acceleration signals until 3 months after total knee arthroplasty
3D lower limb accelerations corresponding to walking bouts will be extracted and transformed by Fast Fourier Transform. The first five pairs of Fourier coefficients will be used for data analysis.
Time frame
Two weeks before the surgery until three months after the surgery2
The postoperative changes from the baseline (preoperative) Fourier coefficients of walking acceleration signals at 12 months after total knee arthroplasty
3D lower limb accelerations corresponding to walking bouts will be extracted and transformed by Fast Fourier Transform. The first five pairs of Fourier coefficients will be used for data analysis.
Time frame
Two weeks before and 12 months after the surgerySecondary outcomes
1
The postoperative daily changes from the baseline (preoperative) cadence until 3 months after total knee arthroplasty
Acceleration data will be analyzed to determine the gait cadence defined as the number of steps taken per minute.
Time frame
Two weeks before the surgery until three months after the surgery2
The postoperative daily changes from the baseline (preoperative) stance time until 3 months after total knee arthroplasty
Acceleration data will be analyzed to determine the stance time of the gait described as the percentage of the gait cycle time spent on stance phase.
Time frame
Two weeks before the surgery until three months after the surgery3
The postoperative daily changes from the baseline (preoperative) rest time until 3 months after total knee arthroplasty
Acceleration data will be analyzed to determine the proportion of time the patient spent lying down during each day expressed as the percentage.
Time frame
Two weeks before the surgery until three months after the surgery4
The postoperative daily changes from the baseline (preoperative) sitting time until 3 months after total knee arthroplasty
Acceleration data will be analyzed to determine the proportion of time the patient spent sitting during each day expressed as the percentage.
Time frame
Two weeks before the surgery until three months after the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Aalborg University
Collaborator
Source ClinicalTrials.gov