Analyzing Orthopedic Patient Experience Patterns in Medical Trials
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Orthopedic Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Comprehensive Study for Analyzing Orthopedic Patient Experience Patterns in Medical Trials
Overview
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.
Primary outcome measures
- Number of patients who decide to enroll in an orthopedic clinical trial [Time frame: 3 months]
- Rate of patients who remain in orthopedic clinical trial to trial completion [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT05483673 · 86809840