NCT04095611 - 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)

Ball S, McAndrew A, Aylward A, Cockcroft E, Gordon E, Kerridge A, Morgan-Trimmer S, Powell R, Price A, Rhodes S, Timperley AJ, van Horik J, Wickins R, Charity J
Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE. Trials. 2022 Nov 5;23(1):924. doi: 10.1186/s13063-022-06790-z.
Price A, Ball S, Rhodes S, Wickins R, Gordon E, Aylward A, Cockcroft E, Morgan-Trimmer S, Powell R, Timperley J, Charity J
Effects of a modified muscle sparing posterior technique in hip hemiarthroplasty for displaced intracapsular fractures on postoperative function compared to a standard lateral approach (HemiSPAIRE): protocol for a randomised controlled trial. BMJ Open. 2021 Jun 8;11(6):e045652. doi: 10.1136/bmjopen-2020-045652.

The Effects of a Modified Muscle Sparing Posterior Technique (SPAIRE) in Hip Hemiarthroplasty for Displaced Intracapsular Fractures on Post-operative Function Compared to a Standard Lateral Approach; a Randomised Controlled Trial

Details for clinical trial NCT04095611

Clinical trial NCT04095611 - References