Status:
TERMINATED
Health Partner Evaluation at Princeton
Lead Sponsor:
DePuy Orthopaedics
Collaborating Sponsors:
Johnson & Johnson Health and Wellness Solutions, Inc.
Conditions:
Total Knee Arthroplasty; Total Hip Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single-center, randomized, comparative, controlled study. Penn Medicine Princeton Medical Center will enroll a total of 296 subjects (18 years or older) who are electing to have...
Eligibility Criteria
Inclusion
- Subjects meeting all the following specific criteria will be considered for participation in the study:
- Subject is 18 years or older at the time of consent.
- Subject must be identified by their provider as needing elective unilateral TKA or THA.
- Subject must have a valid e-mail address and willing to access their inbox on a regular basis.
- Subject must possess a smartphone/device capable of downloading the current version of the Health Partner mobile app and be willing to access and use digital materials for this project.
- Subject must be able to comprehend and comply with the requirements of the study.
- Subject must be able to speak, read and understand English fluently.
- Subject is willing to give voluntary, written informed consent to participate in this service evaluation and authorize the transfer of his/her information to the Sponsor and Business Associate.
- Subjects will be excluded from participation in the study if they meet any of the following criteria:
- Subject is not able to follow the standard of care and would require special care or circumstances.
- Subject scheduled to have TKA or THA less than or equal to 2 weeks (14 days) from the time they are enrolled in the study.
- Subject is undergoing a revision to a previous surgery.
- Subject is undergoing TKA or THA following traumatic injury (i.e. fracture).
- Subject is expected to need another lower limb joint replacement (hip/knee) prior to completing this service evaluation.
- Subject is a repeat patient and was enrolled in the study previously.
- Subject has had prior experience with the Health Partner companion app.
- Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
- Subject, in the opinion of their healthcare provider, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect his/her ability to complete patient reported questionnaires or be compliant with follow-up requirements.
- Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
- Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing activities (e.g., muscular dystrophy, multiple sclerosis, Charcot disease).
Exclusion
Key Trial Info
Start Date :
June 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2019
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT03386786
Start Date
June 30 2017
End Date
December 11 2019
Last Update
January 2 2020
Active Locations (1)
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1
Penn Medicine Princeton Medical Center
Plainsboro, New Jersey, United States, 08536