Proximal Humeral FracturesHIPPINCT07538700
Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial
A study testing Locking plate fixation with femoral allograft augmentation in people with Proximal Humeral Fractures, run by Tergooi Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Proximal Humeral Fractures
- What is being tested?
- Locking plate fixation with femoral allograft augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 May 2025to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Tergooi Medical Center
Hilversum
Dominique C. Baas, PhD, +31887535153, dbaas@tergooi.nl
About this study
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
Read the detailed description
Rationale: 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.
Objective:
Primary Objective: To compare the CMS between patients treated with LCP fixation plus femoral allograft and those treated with LCP fixation alone at 24 months. The CMS is a validated tool used for assessing overall shoulder function, incorporating bothsubjective and objective components.
Secondary Objectives: To assess differences in clinical outcomes (using Oxford Shoulder Score, Subjective Shoulder Value, Numeric Rating Scale, EQ-5DL), radiological outcomes (humeral head height, humeral neck shaft angle), and the incidence of complications at 24 months.
Study design: This is a single-center, prospective, single-blind, two-armed, parallel-group randomized controlled 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.
Study population: The study will enroll adults aged 40-70 years presenting with acute (≤3 weeks) three- or four-part PHFs Intervention: Participants will be randomly assigned to either the intervention group (LCP fixation plus femoral allograft) or the control group (LCP fixation alone).
Main study parameters/endpoints: The main study parameter will be the CMS score at 24 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. The use of allografts carries potential risks, such as infection and immune reactions, but these are minimized through careful donor selection and screening. Bone allografting is gen-erally safe, though risks like infection, bleeding, and impaired healing remain. Hospitalization and mortality risks are very low. The procedure aims to improve stability and reduce complications, supported by existing literature
- Conditions
- Proximal Humeral Fractures
- Being tested
- Locking plate fixation with femoral allograft augmentation
- Keywords
- Plate fixation, Proximal humeral fractures, Femoral allograft, Randomization
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking plate fixation with femoral allograft augmentationProcedure or surgery
Locking plate fixation with femoral allograft augmentation
| Study group | Role | What they receive |
|---|---|---|
| Locking plate fixation alone | No intervention | Locking plate fixation alone |
| Intervention | Experimental | Locking plate fixation with femoral allograft augmentation Receives: Procedure: Locking plate fixation with femoral allograft augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Murley Score
Change in Constant Murley Score
Measured: 24 months
Secondary outcomes (4)
Oxford Shoulder Score
Oxford Shoulder Score
Measured: 6 weeks, 6 months, 12 months and 24 months
NRS
NRS
Measured: 6 weeks, 6 months, 12 months and 24 months
EQ-5D
EQ-5D
Measured: 6 weeks, 6 months, 12 months and 24 months
SSV
SSV
Measured: 6 weeks, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start21 May 2025
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tergooi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura M. Kok, MD, PhD, Principal investigator, Tergooi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538700
- Sponsor's protocol ID
- R24.102
- Other IDs
- NL88103.100.24
- Acronym
- HIPPI
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Supporting data when the request is reasonable
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hip-allograft In Proximal Humerus Fractures Versus Plate Implantation Alone: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07538700
- Acronym / sponsor ID
- HIPPI / R24.102
- Conditions
- Proximal Humeral Fractures
- Keywords
- Plate fixation, Proximal humeral fractures, Femoral allograft, Randomization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Tergooi Medical CenterUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Rationale: 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.
Objective:
Primary Objective: To compare the CMS between patients treated with LCP fixation plus femoral allograft and those treated with LCP fixation alone at 24 months. The CMS is a validated tool used for assessing overall shoulder function, incorporating bothsubjective and objective components.
Secondary Objectives: To assess differences in clinical outcomes (using Oxford Shoulder Score, Subjective Shoulder Value, Numeric Rating Scale, EQ-5DL), radiological outcomes (humeral head height, humeral neck shaft angle), and the incidence of complications at 24 months.
Study design: This is a single-center, prospective, single-blind, two-armed, parallel-group randomized controlled 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.
Study population: The study will enroll adults aged 40-70 years presenting with acute (≤3 weeks) three- or four-part PHFs Intervention: Participants will be randomly assigned to either the intervention group (LCP fixation plus femoral allograft) or the control group (LCP fixation alone).
Main study parameters/endpoints: The main study parameter will be the CMS score at 24 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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. The use of allografts carries potential risks, such as infection and immune reactions, but these are minimized through careful donor selection and screening. Bone allografting is gen-erally safe, though risks like infection, bleeding, and impaired healing remain. Hospitalization and mortality risks are very low. The procedure aims to improve stability and reduce complications, supported by existing literature
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Locking plate fixation alone | No intervention | –Locking plate fixation alone |
| Intervention | Experimental | Procedure: Locking plate fixation with femoral allograft augmentationLocking plate fixation with femoral allograft augmentation |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locking plate fixation with femoral allograft augmentationLocking plate fixation with femoral allograft augmentation | Procedure or surgery | Intervention |
Primary outcome
Constant Murley Score
Time frame: 24 months
Change in Constant Murley Score
4 secondary outcomes
Oxford Shoulder Score
Time frame: 6 weeks, 6 months, 12 months and 24 months
NRS
Time frame: 6 weeks, 6 months, 12 months and 24 months
EQ-5D
Time frame: 6 weeks, 6 months, 12 months and 24 months
SSV
Time frame: 6 weeks, 6 months, 12 months and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Supporting data when the request is reasonable
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura M. Kok, MD, PhD principal investigator
Tergooi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locking plate fixation with femoral allograft augmentation in people with Proximal Humeral Fractures, run by Tergooi Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique C Baas, PhD (+31887535153, dbaas@tergooi.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Murley Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.