Wearable Sensors for Monitoring Recovery After Total Knee Arthroplasty

NCT05992064 | Recruiting

• 1 other identifier: F2022-196
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (20)

• The postoperative daily changes from the baseline (preoperative) cadence until 3 months after total knee arthroplasty

  Two weeks before the surgery until three months after the surgery

• The postoperative daily changes from the baseline (preoperative) stance time until 3 months after total knee arthroplasty

  Two weeks before the surgery until three months after the surgery

• The postoperative daily changes from the baseline (preoperative) rest time until 3 months after total knee arthroplasty

  Two weeks before the surgery until three months after the surgery

• The postoperative daily changes from the baseline (preoperative) sitting time until 3 months after total knee arthroplasty

  Two weeks before the surgery until three months after the surgery

• The postoperative daily changes from the baseline (preoperative) standing time until 3 months after total knee arthroplasty

  Two weeks before the surgery until three months after the surgery

Interventions

Measuring gait OTHER

Measurements 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.

Also known as: Measuring PA levels

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients who are scheduled for TKA from a certain date onwards will be screened and offered participation in the study.

You may qualify if:

• Patients diagnosed with knee OA and scheduled to undergo unilateral TKA at Aalborg University Hospital, Farsø.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Regionshospital Nordjylland, Frederikshavn

Frederikshavn, North Denmark, 9900, Denmark

RECRUITING

Related Publications (14)

• Steinhaus ME, Christ AB, Cross MB. Total Knee Arthroplasty for Knee Osteoarthritis: Support for a Foregone Conclusion? HSS J. 2017 Jul;13(2):207-210. doi: 10.1007/s11420-017-9558-4. Epub 2017 May 16.

  PMID: 28690473 BACKGROUND

• Feng JE, Novikov D, Anoushiravani AA, Schwarzkopf R. Total knee arthroplasty: improving outcomes with a multidisciplinary approach. J Multidiscip Healthc. 2018 Jan 25;11:63-73. doi: 10.2147/JMDH.S140550. eCollection 2018.

  PMID: 29416347 BACKGROUND

• Bolam SM, Batinica B, Yeung TC, Weaver S, Cantamessa A, Vanderboor TC, Yeung S, Munro JT, Fernandez JW, Besier TF, Monk AP. Remote Patient Monitoring with Wearable Sensors Following Knee Arthroplasty. Sensors (Basel). 2021 Jul 29;21(15):5143. doi: 10.3390/s21155143.

  PMID: 34372377 BACKGROUND

• Tiwari V, Lee J, Sharma G, Kang YG, Kim TK. Temporal patterns of commonly used clinical outcome scales during a 5-year period after total knee arthroplasty. J Orthop Traumatol. 2019 Mar 25;20(1):16. doi: 10.1186/s10195-019-0520-8.

  PMID: 30911852 BACKGROUND

• Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.

  PMID: 16534088 BACKGROUND

• Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.

  PMID: 27417610 BACKGROUND

• Carson JL, Kelley MA, Duff A, Weg JG, Fulkerson WJ, Palevsky HI, Schwartz JS, Thompson BT, Popovich J Jr, Hobbins TE, et al. The clinical course of pulmonary embolism. N Engl J Med. 1992 May 7;326(19):1240-5. doi: 10.1056/NEJM199205073261902.

  PMID: 1560799 BACKGROUND

• Iovanel G, Ayers D, Zheng H. The Role of Wearable Technology in Measuring and Supporting Patient Outcomes Following Total Joint Replacement: Review of the Literature. JMIR Perioper Med. 2023 Jan 12;6:e39396. doi: 10.2196/39396.

  PMID: 36633891 BACKGROUND

• Sliepen M, Lipperts M, Tjur M, Mechlenburg I. Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. EFORT Open Rev. 2020 Jan 28;4(12):678-685. doi: 10.1302/2058-5241.4.180041. eCollection 2019 Dec.

  PMID: 32010456 BACKGROUND

• Mendiratta P, Schoo C, Latif R. Clinical Frailty Scale. 2023 Apr 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559009/

  PMID: 32644435 BACKGROUND

• Ghaffari A, Rahbek O, Lauritsen REK, Kappel A, Kold S, Rasmussen J. Criterion Validity of Linear Accelerations Measured with Low-Sampling-Frequency Accelerometers during Overground Walking in Elderly Patients with Knee Osteoarthritis. Sensors (Basel). 2022 Jul 15;22(14):5289. doi: 10.3390/s22145289.

  PMID: 35890969 BACKGROUND

• Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.

  PMID: 9699158 BACKGROUND

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

  PMID: 11491192 BACKGROUND

• Healy WL, Della Valle CJ, Iorio R, Berend KR, Cushner FD, Dalury DF, Lonner JH. Complications of total knee arthroplasty: standardized list and definitions of the Knee Society. Clin Orthop Relat Res. 2013 Jan;471(1):215-20. doi: 10.1007/s11999-012-2489-y.

  PMID: 22810157 BACKGROUND

Study Officials

• Ole Rahbek, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arash Ghaffari, MD

CONTACT

+45-91483966; a.ghaffari@rn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 15, 2023
• Study Start: March 12, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2024-07

Locations

DK (1)