Clinical Outcomes of the ALPS Proximal Humerus Plating System
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/12/2019 |
| Start Date: | August 7, 2017 |
| End Date: | August 1, 2022 |
| Contact: | Julie M Daniels |
| Email: | Julie.M.Daniels@Vanderbilt.edu |
| Phone: | 615-322-4506 |
The purpose of this study is to document the performance and clinical outcomes of the
A.L.P.S® Proximal Humerus Plating System.
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician
assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and
work/leisure restrictions
- Document revisions, complications, and adverse events
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population. DXA is not particularly effective at identifying
individuals who are at risk of suffering a fracture. Yet, there is a growing population of
diabetics and elderly individuals prone to fragility fractures. In effect, the age-related
and diabetes-related increase in fracture risk is independent of a person's aBMD. These
findings stress the urgency in developing diagnostic tools that can improve fracture risk
prediction so that patients can be treated with the appropriate anti-fracture therapies.
Shifting from the current paradigm of using X-ray based modalities to assess fracture risk,
the reference point indentation (RPI) method acquires direct measurements of 'materal
quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and
upon applying an impact force, it measures the ability of the tissue to resist
micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to
bone, there is no evidence that a local measurement of bone material quality are predictive
of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal
humerus).
By affirming the ability of RPI to discriminate a fragility fracture from a high-energy
(trauma) fracture of otherwise normal bone, the data from this optional study arm may provide
justification for large prospective studies that evaluate whether intra-operative RPI is
useful for surgical guidance.
A.L.P.S® Proximal Humerus Plating System.
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician
assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and
work/leisure restrictions
- Document revisions, complications, and adverse events
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population. DXA is not particularly effective at identifying
individuals who are at risk of suffering a fracture. Yet, there is a growing population of
diabetics and elderly individuals prone to fragility fractures. In effect, the age-related
and diabetes-related increase in fracture risk is independent of a person's aBMD. These
findings stress the urgency in developing diagnostic tools that can improve fracture risk
prediction so that patients can be treated with the appropriate anti-fracture therapies.
Shifting from the current paradigm of using X-ray based modalities to assess fracture risk,
the reference point indentation (RPI) method acquires direct measurements of 'materal
quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and
upon applying an impact force, it measures the ability of the tissue to resist
micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to
bone, there is no evidence that a local measurement of bone material quality are predictive
of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal
humerus).
By affirming the ability of RPI to discriminate a fragility fracture from a high-energy
(trauma) fracture of otherwise normal bone, the data from this optional study arm may provide
justification for large prospective studies that evaluate whether intra-operative RPI is
useful for surgical guidance.
The purpose of this study is to document the performance and clinical outcomes of the
A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician
assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and
work/leisure restrictions
- Document revisions, complications, and adverse events
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population. DXA is not particularly effective at identifying
individuals who are at risk of suffering a fracture. Yet, there is a growing population of
diabetics and elderly individuals prone to fragility fractures. In effect, the age-related
and diabetes-related increase in fracture risk is independent of a person's aBMD. These
findings stress the urgency in developing diagnostic tools that can improve fracture risk
prediction so that patients can be treated with the appropriate anti-fracture therapies.
Shifting from the current paradigm of using X-ray based modalities to assess fracture risk,
the reference point indentation (RPI) method acquires direct measurements of 'materal
quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and
upon applying an impact force, it measures the ability of the tissue to resist
micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to
bone, there is no evidence that a local measurement of bone material quality are predictive
of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal
humerus).
By affirming the ability of RPI to discriminate a fragility fracture from a high-energy
(trauma) fracture of otherwise normal bone, the data from this optional study arm may provide
justification for large prospective studies that evaluate whether intra-operative RPI is
useful for surgical guidance.
A.L.P.S® Proximal Humerus Plating System.
Specific Aims:
- Conduct physical assessments measuring shoulder strength and range of motion, physician
assessment of radiographs
- Obtain patient-reported outcomes regarding pain level, function capabilities, and
work/leisure restrictions
- Document revisions, complications, and adverse events
The optional, interventional arm of this study will assess bone quality in the proximal
humerus of a fracture patient population. DXA is not particularly effective at identifying
individuals who are at risk of suffering a fracture. Yet, there is a growing population of
diabetics and elderly individuals prone to fragility fractures. In effect, the age-related
and diabetes-related increase in fracture risk is independent of a person's aBMD. These
findings stress the urgency in developing diagnostic tools that can improve fracture risk
prediction so that patients can be treated with the appropriate anti-fracture therapies.
Shifting from the current paradigm of using X-ray based modalities to assess fracture risk,
the reference point indentation (RPI) method acquires direct measurements of 'materal
quality' of the bone tissue. Specifically, the OsteoProbe-RPI engages the patient's bone, and
upon applying an impact force, it measures the ability of the tissue to resist
micro-indentation. Despite the encouraging results from aformentioned studies applying RPI to
bone, there is no evidence that a local measurement of bone material quality are predictive
of fracture resistance at sites that are prone to fragility fractures (e.g. the proximal
humerus).
By affirming the ability of RPI to discriminate a fragility fracture from a high-energy
(trauma) fracture of otherwise normal bone, the data from this optional study arm may provide
justification for large prospective studies that evaluate whether intra-operative RPI is
useful for surgical guidance.
Inclusion Criteria:
- Patients who present with a proximal humerus fracture requiring primary or revision
ORIF using A.L.P.S Proximal Humerus Plating System
- Patients who present with a proximal humerus fracture that involves the metaphysis
- 18 years or older
Exclusion Criteria:
- Patients under the age of 18
- Patients who have an infection, sepsis, or osteomyelitis
- Patients who are unwilling to take part in study, have documented psychiatric disorder
that limits ability to consent and maintain follow-up, or who may have severe problems
maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually
changed without adequate family support)
- Patients who do not speak English (do to unavailability of non-English surveys)
- Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
- Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the
last 5 years or whose treatment lasted longer than 5 years
- Patients who have Type 1 diabetes
- Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease,
thyroid disease, Vitamin D deficiency, hyperparathyroidism)
- Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
We found this trial at
1
site
1215 21st Avenue South
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Principal Investigator: Mihir J Desai, MD
Phone: 615-322-4506
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