HIPPI shoulder - Hip-allograft In Proximal humerus fractures versus Plate Implantation alone: a randomized controlled trial

Proximal humerus fractures (PHFs) are common osteoporotic fractures in adults
and the el-derly, leading to significant disability and reduced quality of life
(QoL). Current treatment op-tions for displaced PHFs include locking plate
fixation (LCP) and various augmentation tech-niques, 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 com-bined 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.

The aim of this RCT is to examine the differences in functional, clinical, and
radiological out-comes, between LCP fixation alone and femoral allograft
augmentation in addition to LCP. Ultimately, the purpose is to optimize
treatment strategies and enhance long-term quality of life outcomes in the
management of displaced PHFs.

This is a single-center, prospective, single-blind, two-armed, parallel-group
randomized con-trolled trial (RCT) to be conducted at Tergooi MC. The study
will span a maximum of 48 months, including 24 months for patient recruitment
and 24 months for follow-up.

All measurements and actions outlined below will be identical for both groups.

1) Patient selection
Patients presenting with a proximal humerus fracture (PHF) at the orthopedics
department of Tergooi will be screened based on established inclusion and
exclusion criteria. Once they meet these criteria, they will be informed about
the study, and written informed consent will be obtained.

2) Randomization and Blinding
Variable, single-blind, blocked randomization will be conducted, stratified by
dominant arm, gender (male and female), age, and fracture classification
(3-part and 4-part), with an allocation ratio of 1:1, executed via the Castor
EDC system.

The study coordinator will inform the surgeon of the assigned treatment for the
patients: either LCP fixation alone or femoral allograft augmentation in
combination with LCP fixation.

The specialized shoulder physiotherapist conducting the measurements will
remain unaware of the patients* treatment groups, and patients will be
encouraged not to disclose their treatment group

3) Intervention
The surgery will be performed with same-day admission, allowing patients to
return home on the same day.

4) Measurements and follow-up
To test our hypothesis, we will collect data at various follow-up points after
the surgery using standardized measurements and questionnaires. These
measurements and questionnaires will be identical for both groups.

The primary and secondary outcome measurements will occur at the following time
points:

- Pre-operative baseline measurement (T0)
- 6 weeks post-operative (T1)
- 6 months post-operative (T2)
- 12 months post-operative (T3)
- 24 months post-operative (T4)

Chapter 3 and Chapter 8 of the research protocol, particularly section 8.3,
provide a detailed description of the study procedures.

This study compares two treatment methods: locking plate fixation (LCP) alone
and LCP fixation combined with a femoral allograft. The study is designed with
two groups of patients, with each group undergoing one of the mentioned
treatments. The patients are randomized in a 1:1 ratio into these groups.

Group 1: the standard of care group, in which only LCP fixation is performed.

Group 2: the intervention group, in which a femoral allograft is added to the
LCP fixation. Further visual and detailed explanations regarding these groups
can be found in the research protocol, with an extensive description in Chapter
5: Treatment of Subjects.

Participation in this study involves no additional burden compared to standard
care at Tergooi MC. The study uses routine shoulder function assessments
already part of the follow-up protocol, with no extra hospital visits, invasive
procedures, or questionnaires required. The risks associated with the
investigational treatments are minimal, similar to those observed in previous
studies on fibular and femoral allografts. Hospitalization and mortality risks
are very low. The procedure aims to improve stability and reduce complications,
supported by existing literature.

At Tergooi MC both techniques are already being used in the treatment of
proximal humerus fractures: both "plate implantation" (plate with screws) alone
and the combination with the "hip allograft" (plate with screws and a graft).
Outside the study, the surgeon selects the most appropriate treatment option
for the patient. Since both treatments are already standard practice, we do not
expect any additional burden or risks.