Analyzing Orthopedic Patient Experience Patterns in Medical Trials

NCT05483673 | Not Yet Recruiting

• 1 other identifier: 86809840
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Orthopedic Disorder

Keywords

orthopedic

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

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

Study Population

Orthopedic disorder patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

• ECOG score of 4
• Patient is pregnant
• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 29560527 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.

  PMID: 17671026 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.

  PMID: 27142421 BACKGROUND

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12