Limited Market Release - MotionSense Clinical Use Evaluation

NCT05091918 | Completed Results FDA Device

• 1 other identifier: Orthosensor
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

Prospective evaluation of patient compliance and prescribed home exercise program using MotionSense wearable system during recovery from primary total knee arthroplasty.

Conditions

Knee Arthroplasty; Patient Engagement; Patient-Reported Outcome Measures (PROMs)

Keywords

MotionSense

Outcome Measures

Primary Outcomes (6)

• Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Hours of MotionSense Use Per Day in Office

  Hours spent per day in office by practice using MotionSense wearable system, from 30 days preoperative to 90 days postoperative.

  30 days preoperative to 90 days postoperative

• Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Number of Days Use After / Prior to Surgery

  Initial and last day worn while wearing MotionSense from 30 days preoperative to 90 days postoperative

  30 days preoperative to 90 days postoperative

• Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Filled Out Questionnaires

  Count of participants who have completed the aggregate questionnaires in the MotionSense App downloaded to their mobile devices at each timepoint for evaluation of compliance with the MotionSense Wearable System.

  Preoperative, 2 weeks postoperative, 6 weeks postoperative, 90 days postoperative

• Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Home Exercise Program

  Percent of exercise sessions completed while wearing MotionSense from 30 days preoperative to 90 days postoperative. An exercise session is a collection of exercises that can be customized and assigned to a patient to be performed either once or twice a day.

  30 days preoperative to 90 days postoperative

• Evaluate Patient and Practice Compliance With the MotionSense Wearable System: Patient Onboarding Time in Surgeon Clinic

  Minutes spent per patient at preoperative onboarding visit. Onboarding visit provided patients with instructions on system use and initial wearable installation.

  Preoperative onboarding visit

• Document Home Exercise Program Prescribed to Patients Throughout Their Individualized Recovery Progress by Surgeons and Physiotherapists

  Daily percentage of patients prescribed each home exercise during preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative time periods. Isometric quads: Lie back to floor, tense quadriceps, hold, repeat. Sit-to-stands: Sit, stand, strengthen, repeat. Short-arc quadriceps: Lie back to floor with leg bent, extend leg, hold, repeat. Heel slides: Lie back to floor, slide and bend leg, hold, repeat. Hamstring curls: Lie stomach to floor, bend leg, hold, repeat. Long-arc quadriceps: Sit, lift, hold, count, repeat, strengthen. Straight leg raises: Lie back to floor, lift leg, hold, lower, repeat. Standing knee bends: Stand, squat, knees, lower, maintain form, repeat. Knee straightening stretches: Lie back to floor, extend leg, tense, relax. Sitting knee bends: Sit, hold, stretch, hold, slide, repeat. Assisted knee stretches: Sit, bend, hold, release, repeat. Warmup: 5 minutes

  Preoperative, 1-30 days postoperative, 31-60 days postoperative, 61-90 days postoperative

Secondary Outcomes (9)

• Correlate Functional and Patient Reported Outcome Metrics

  2 weeks, 6 weeks, 90 days postoperative

• Evaluate Convenience of Using the MotionSense System: Number of Leg Registrations Performed (Per Day)

  30 days preoperative to 90 days postoperative

• Evaluate Convenience of Using the MotionSense System: Number of (Weekly / Daily) Patches Used

  30 days preoperative to 90 days postoperative

• Evaluate Convenience of Using the MotionSense System: Number of Wound Pictures Shared With Surgeon Office

  30 days preoperative to 90 days postoperative

• Establish Normative Recovery Data for the Primary Outcome Metrics Captured by the MotionSense System: Daily VAS Pain Scores

  30 days preoperative to 90 days postoperative

Study Arms (1)

MotionSense Wearable

OTHER

Using MotionSense from pre-op to 90 days post-op during the recovery after primary TKA

Device: MotionSense

Interventions

MotionSense DEVICE

MotionSense Wearable: Remote patient monitoring

MotionSense Wearable

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for unilateral total knee surgery in the coming 4 weeks
• Age 50 to 80
• Owns a smart phone

You may not qualify if:

• BMI exceeding 35
• Severe skin conditions

Sponsors & Collaborators

• Orthosensor, Inc.: lead

Study Sites (2)

Oklahoma Joint Reconstruction Institute

Oklahoma City, Oklahoma, 73114, United States

Location

Robotic Joint Replacement Institute LLC

Wakefield, Rhode Island, 02879, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Comment for Document Section: Initially the Ethical Review Committee did not request a detailed Statistical Analysis Plan. The Statistical Analysis Plan was uploaded to describe the standard analysis for descriptive statics. The study concluded on August 1, 2022. Therefore, belated IRB approval of the standard statistical analysis plan was not requested.

Results Point of Contact

• Title: Kevin Barga
• Organization: Stryker

Kevin.Barga@stryker.com

+12018315073

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 25, 2021
• Study Start: May 27, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 10, 2024
• Results First Posted: September 7, 2023

Record last verified: 2024-06

Locations

US (2)