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

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

This trial will see if adding a mushroom-shaped femoral bone graft to locking-plate fixation helps adults aged 40–70 with recent 3- or 4-part proximal humerus fractures regain better shoulder function than plate fixation alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Tergooi Medical Center (other)
• Locations: 1 site (Hilversum)
• Trial ID: NCT07538700 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Dutch-speaking adults aged 40–70 with an acute (<3 weeks) displaced 3- or 4-part proximal humerus fracture who can give informed consent and complete follow-up.

Not a fit: Patients with head-split or pathological fractures, prior surgery or prior fracture of the same shoulder, active infection, dementia or other cognitive impairment, seizures, collagen diseases, or other conditions limiting shoulder mobility are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve long-term shoulder function and reduce fixation failures after complex proximal humerus fractures.

How similar studies have performed: Small series and case reports have reported promising results for femoral allograft augmentation, but randomized controlled evidence is limited.

Eligibility criteria

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 this trial is running

Hilversum

• Tergooi Medical Center — Hilversum, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Laura M. Kok, MD, PhD — Tergooi Medical Center
• Study coordinator: Dominique C Baas, PhD

Conditions: Proximal Humeral Fractures, Plate fixation, Proximal humeral fractures, Femoral allograft, Randomization