Arthroplasty, Replacement, Knee Clinical Trial
Official title:
Investigating the Potential of Wearable Sensors for Monitoring the Postoperative Recovery of Total Knee Arthroplasty Patients: A Protocol for Prospective Longitudinal Observational Study
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | October 1, 2025 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with knee OA and scheduled to undergo unilateral TKA at Aalborg University Hospital, Farsø. Exclusion Criteria: - 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) - Neurological movement disorders - Inflammatory arthritis - Patients who are not smartphone users - Frail patients with clinical frailty scale (CFS)10 = 5 - Residents of nursing homes - Patients dependent to walking aids for ambulation - Patients with dementia or memory problems - Patients with skin sensitivity or issues at the location of the plasters. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Aalborg University Hospital | Aalborg University |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Two weeks before the surgery until three months after the surgery | |
Primary | 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. | Two weeks before and 12 months after the surgery | |
Secondary | 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. | Two weeks before the surgery until three months after the surgery | |
Secondary | 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. | Two weeks before the surgery until three months after the surgery | |
Secondary | 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. | Two weeks before the surgery until three months after the surgery | |
Secondary | 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. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative daily changes from the baseline (preoperative) standing time until 3 months after total knee arthroplasty | Acceleration data will be analyzed to determine the proportion of time the patient spent standing during each day expressed as the percentage. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative daily changes from the baseline (preoperative) walking time until 3 months after total knee arthroplasty | Acceleration data will be analyzed to determine the proportion of time the patient spent walking during each day expressed as the percentage. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative daily changes from the baseline (preoperative) step counts until 3 months after total knee arthroplasty | Acceleration data will be analyzed to determine the number of steps the patient takes during each day. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative daily changes from the baseline (preoperative) sit-to-stand counts until 3 months after total knee arthroplasty | Acceleration data will be analyzed to determine the number of sit-to-stands the patient performs during each day. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative daily changes from the baseline (preoperative) activity count index until 3 months after total knee arthroplasty | The activity count index will be calculated by using the variance of the magnitude of the linear accelerations and demonstrates the quantitative level of PA. | Two weeks before the surgery until three months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) cadence at 12 months after total knee arthroplasty | Acceleration data will be analyzed to determine the gait cadence defined as the number of steps taken per minute. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) stance time at 12 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. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) rest time at 12 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. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) sitting time at 12 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. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) standing time at 12 months after total knee arthroplasty | Acceleration data will be analyzed to determine the proportion of time the patient spent standing during each day expressed as the percentage. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) walking time at 12 months after total knee arthroplasty | Acceleration data will be analyzed to determine the proportion of time the patient spent walking during each day expressed as the percentage. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) step counts at 12 months after total knee arthroplasty | Acceleration data will be analyzed to determine the number of steps the patient takes during each day. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) sit-to-stand counts at 12 months after total knee arthroplasty | Acceleration data will be analyzed to determine the number of sit-to-stands the patient performs during each day. | Two weeks before and 12 months after the surgery | |
Secondary | The postoperative changes from the baseline (preoperative) activity count index at 12 months after total knee arthroplasty | The activity count index will be calculated by using the variance of the magnitude of the linear accelerations and demonstrates the quantitative level of PA. | Two weeks before and 12 months after the surgery | |
Secondary | The change in Knee injury and Osteoarthritis Outcome Score (KOOS) | The KOOS questionnaire is an instrument to assess the patient's opinion about their knee and associated problems. Only the domains evaluating the pain, symptoms and functions of daily activities will be used. | Baseline (2 weeks before surgery); and 1 month, 2 months, 3 months, and 12 months after the surgery. | |
Secondary | The change in EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) questionnaire | EQ-5D-3L is a generic tool for Patient Reported Outcomes (PRO) measurement that can assess patients' quality of life, irrespective of the disease. | Baseline (2 weeks before surgery); and 1 month, 2 months, 3 months, and 12 months after the surgery. |
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