NCT07538700

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
36mo left

Started May 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
May 2025May 2029

Study Start

First participant enrolled

May 21, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Proximal Humeral Fractures

Keywords

Plate fixationProximal humeral fracturesFemoral allograftRandomization

Outcome Measures

Primary Outcomes (1)

  • Constant Murley Score

    Change in Constant Murley Score

    24 months

Secondary Outcomes (4)

  • Oxford Shoulder Score

    6 weeks, 6 months, 12 months and 24 months

  • NRS

    6 weeks, 6 months, 12 months and 24 months

  • EQ-5D

    6 weeks, 6 months, 12 months and 24 months

  • SSV

    6 weeks, 6 months, 12 months and 24 months

Study Arms (2)

Locking plate fixation alone

NO INTERVENTION

Locking plate fixation alone

Intervention

EXPERIMENTAL

Locking plate fixation with femoral allograft augmentation

Procedure: Locking plate fixation with femoral allograft augmentation

Interventions

Locking plate fixation with femoral allograft augmentationPROCEDURE

Locking plate fixation with femoral allograft augmentation

Intervention

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tergooi Medical Center

Hilversum, Netherlands

RECRUITING

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesShoulder Injuries

Study Officials

  • Laura M. Kok, MD, PhD

    Tergooi Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique C Baas, PhD

CONTACT

+31887535153dbaas@tergooi.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

May 21, 2025

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Supporting data when the request is reasonable

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Beginning after publication with no end date.
Access Criteria
Anyone will be able to access the qualitative supportive data via an online data repository.

Locations

NL(1)