NCT06416618 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Alispahic N, Brorson S, Bahrs C, Joeris A, Steinitz A, Audige L
Complications after surgical management of proximal humeral fractures: a systematic review of event terms and definitions. BMC Musculoskelet Disord. 2020 May 26;21(1):327. doi: 10.1186/s12891-020-03353-8.
Audige L, Brorson S, Durchholz H, Lambert S, Moro F, Joeris A
Core set of unfavorable events of proximal humerus fracture treatment defined by an international Delphi consensus process. BMC Musculoskelet Disord. 2021 Nov 30;22(1):1002. doi: 10.1186/s12891-021-04887-1.
Brorson S, Alispahic N, Bahrs C, Joeris A, Steinitz A, Audige L
Complications after non-surgical management of proximal humeral fractures: a systematic review of terms and definitions. BMC Musculoskelet Disord. 2019 Feb 23;20(1):91. doi: 10.1186/s12891-019-2459-6.
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S
Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years: a Pragmatic Randomized Controlled Trial

Clinical trial NCT06416618 - References