NCT05992064 Wearable Sensors for Monitoring Recovery After Total Knee Arthroplasty
| NCT ID | NCT05992064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Arthroplasty, Replacement, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-03-12 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Ole Rahbek, MD, PhD
PRINCIPAL INVESTIGATOR
Aalborg University Hospital
Frequently Asked Questions
Who can join the NCT05992064 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Arthroplasty, Replacement, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05992064 currently recruiting?
Yes, NCT05992064 is actively recruiting participants. Contact the research team at a.ghaffari@rn.dk for enrollment information.
Where is the NCT05992064 trial being conducted?
This trial is being conducted at Frederikshavn, Denmark.
Who is sponsoring the NCT05992064 clinical trial?
NCT05992064 is sponsored by Aalborg University Hospital. The principal investigator is Ole Rahbek, MD, PhD at Aalborg University Hospital. The trial plans to enroll 30 participants.