Mushroom-shaped femoral bone graft plus locking plate versus locking plate alone for 3- and 4-part proximal humerus fractures.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center randomized trial at Tergooi Medical Center compares locking-plate fixation with and without mushroom-shaped femoral allograft augmentation for displaced 3- and 4-part proximal humerus fractures. Eligible patients are adults aged 40–70 presenting within three weeks of injury and able to consent and communicate in Dutch. The primary outcome is the Constant-Murley Score at 24 months, with secondary outcomes including Oxford Shoulder Score, Subjective Shoulder Value, pain scores, quality of life (EQ-5D- L), radiographic measures, and complication rates. Participants are randomized to receive either LCP fixation plus allograft or LCP fixation alone and followed for clinical and radiological outcomes up to 24 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Tergooi Medical Center
  Hilversum, Netherlands Recruiting

Study contacts

• Principal investigator: Laura M. Kok, MD, PhD — Tergooi Medical Center
• Study coordinator: Dominique C Baas, PhD
• Email: dbaas@tergooi.nl
• Phone: +31887535153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.