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Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial

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Summary

This registry entry documents NIH ClinicalTrials.gov study NCT07538700, a randomized controlled trial evaluating the effectiveness of mushroom-shaped femoral allograft augmentation combined with locking compression plate fixation versus locking compression plate fixation alone for displaced 3- and 4-part proximal humerus fractures in adults and the elderly. The study will assess clinical and functional outcomes at 24 months post-operatively. No regulatory obligations or compliance actions are imposed by this registration document.

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What changed

This ClinicalTrials.gov registry entry records a newly registered randomized controlled trial, NCT07538700, examining whether adding a mushroom-shaped femoral allograft to locking plate fixation improves outcomes over locking plate fixation alone for displaced proximal humerus fractures. The trial targets adult and elderly patients with 3- or 4-part fractures and will follow participants for 24 months post-operatively. Healthcare providers, orthopedic surgeons, and clinical trial sponsors involved in fracture management research should note this study as a contributing evidence source for future treatment guideline development, though this registry entry itself imposes no compliance obligations.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial

N/A NCT07538700 Kind: NA Apr 20, 2026

Abstract

Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults and the elderly, leading to significant disability and reduced quality of life. Current treatment options for displaced PHFs include locking plate fixation (LCP) and various augmentation techniques, but there is no consensus on the optimal treatment. Although, femoral allografts have shown promising results, there is a need for more definitive evidence regarding the utilization of femoral graft augmentation in addition to locking plate fixation in 3- and 4-part PHFs. This study aims to evaluate the effectiveness of using a mushroom-shaped femoral allograft combined with LCP fixation compared to LCP fixation alone. We hypothesize that femoral allograft augmentation with LCP fixation will result in better clinical and functional outcomes than LCP fixation alone at 24 months post-operative

Conditions: Proximal Humeral Fractures

Interventions: Locking plate fixation with femoral allograft augmentation

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Clinical trial registration Orthopedic surgery research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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