RecruitingNot ApplicableNCT07538700

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

Sponsor

Tergooi Medical Center

Enrollment

56 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

Proximal Humeral Fractures

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 70 Years

Inclusion Criteria2

Patients between 40 and 70 years
Presenting with acute (< 3 weeks) 3- or 4-part PHF (NEER classification) Be able to understand and communicate in Dutch; Patient must be competent to make decisions; Patient is willing and able to complete scheduled study procedures Provide written IC.

Exclusion Criteria4

Head-split fractures;
Pathological fractures due to malignancy or metastases;
Individuals diagnosed with dementia or residing in institutional care or other cognitive impairment;
Terminal illness; Patients with convulsive disorders, collagen diseases, and any other condition that might affect the mobility of the shoulder joint; Active joint or systemic infection; History of prior surgery on the same shoulder; Previous fracture in the same shoulder; Psychiatric illness that precludes informed consent.

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