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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who decide to enroll in an orthopedic clinical trial | 3 months | |
| Rate of patients who remain in orthopedic clinical trial to trial completion | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Orthopedic disorder patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael B Gill | Contact | 4159004227 | bask@withpower.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael B Gill | Power Life Sciences Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29560527 | Background | 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. | |
| 17671026 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Jul 28, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| 27142421 | Background | 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. |