Orthopedic Disorder Clinical Trial
Official title:
A Comprehensive Study for Analyzing Orthopedic Patient Experience Patterns in Medical Trials
| NCT number | NCT05483673 |
| Other study ID # | 86809840 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2024 |
| Est. completion date | August 2026 |
Clinical study enrollment has historically been heavily biased toward specific demographics. Several people will be invited to participate in this study so that it may collect a variety of data about orthopedic clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with orthopedic disorders who are invited to take part in medical research will benefit from the analysis of the data.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient has been diagnosed with orthopedic disorder - Patient has self-identified as planning to enroll in an interventional clinical trial - Patient is 18 years old Exclusion Criteria: - ECOG score of 4 - Patient is pregnant - Inability to perform regular electronic reporting - Patient does not understand, sign, and return consent form |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Hollis AC, Davis ET. Understanding the factors that influence patient participation in Orthopaedic Clinical Trials. Int Orthop. 2018 Aug;42(8):1769-1774. doi: 10.1007/s00264-018-3890-2. Epub 2018 Mar 20. — View Citation
Somerson JS, Bartush KC, Shroff JB, Bhandari M, Zelle BA. Loss to follow-up in orthopaedic clinical trials: a systematic review. Int Orthop. 2016 Nov;40(11):2213-2219. doi: 10.1007/s00264-016-3212-5. Epub 2016 May 3. — View Citation
Trippel SB, Bosse MJ, Heck DA, Wright JG. Symposium. How to participate in orthopaedic randomized clinical trials. J Bone Joint Surg Am. 2007 Aug;89(8):1856-64. doi: 10.2106/JBJS.F.01596. No abstract available. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to enroll in an orthopedic clinical trial | 3 months | ||
| Primary | Rate of patients who remain in orthopedic clinical trial to trial completion | 12 months |
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