To conform the procedural safety of the OSSURE LOEP Kit in the specific clinical setting of use in the femoral neck in patients with osteoporosis. Secondary objective: To evaluate the post-market clinical performance of the OSSURE LOEP Kit.
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of all adverse events occurring during the first forty-two (42)
day follow-up period determined to be at least possibly related to the
procedure and/or device for the local treatment of osteoporosis.
Secondary outcome
• The ability to deliver the necessary amount of OSSURE material to fill the
osseous defect as assessed by the treating doctor.
• The ability to access the intended treatment site and successfully inject the
material.
Background summary
Osteoporosis is the most common bone disease worldwide and is the main
underlying cause of fractures in postmenopausal women and the elderly
(prevalence increased due to aging). Bone fractures occur mainly because the
bone strength is no longer sufficient, the most foremost locations are: the
vertebral column, the wrist and the hip. Current treatment for osteoporosis is
to inform patients in combination with nutrition, movement and medication.
Despite current therapy, there is still an increase in hip fractures due to
osteoporosis. The LOEP increases bone growth, enhancing the hip. Because this
occurs only in part of the hip, it is not a substitute for current therapy but
rather a supplement.
Study objective
To conform the procedural safety of the OSSURE LOEP Kit in the specific
clinical setting of use in the femoral neck in patients with osteoporosis.
Secondary objective: To evaluate the post-market clinical performance of the
OSSURE LOEP Kit.
Study design
The CONFIRM study is a prospective, Multi-centre, non-randomised and
non-blinded study with a medical device (OSSURE LOEP kit) for the treatment of
osteoporosis, In total a maximum of 60 patients will participate in the study
in different sites within Europe.
Intervention
The medical device is the OSSURE LOEP Kit (i.e., kit for local strengthening of
the proximal (upper) femur, which means hip). Part of this product is a
synthetic (i.e., man-made), calcium-based implant. The components of the
implant are similar to components of normal bone.
The intervention is performed under sedation or local anesthesia (dependin ont
eh patient) and will take about 60 minutes.The physician will make an incision
on the outer side of the tight and will drill until they reach the space in the
femoral neck. The femoral neck of osteoporotic patients
contains poorly-connected and non-load bearing trabecular bone, fluid, fat, and
marrow elements. This non-structural tissue is then removed using a probe
debrider, irrigation and suction. The AGN1 implant device is placed inside a
delivery syringe and manually injected under low pressure delivered into the
injection site.
Study burden and risks
There are several risks and inconveniences associated with participation in the
procedures and tests required in this clinical trial, like blood sampling,
DXAscan, CT scan (optional) and X-Ray. There are also risks similar to those
associated with other hip procedures, like pain, irritation, infection, blood
vessel injury, implant leakage, blood clots, wound problems, hip fracture,
break down of bone.
However it is believed that patients that are not participating in the study
also underdo most of these assessments and procedures and are therefore exposed
to similar risks.
Patiënts can continue their standard of care treatment, the study procedure is
additional to the standard of care. The investigational medical device may
increase the strength of the hip bone and potentially reduce the occurrence of
hip fractures in postmenopausal women diagnosed with osteoporosis. The hip bone
strength may increase, decrease or remain at the same level during this study.
The risk of hip fracture may also increase, decrease or remain at the same
level. Study participation may not give direct benefits but may also benefit
patients with osteoporosis in the future.
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Listed location countries
Age
Inclusion criteria
1. Subject is postmenopausal female (at least 1-year post menses)
2. Subject has osteoporosis as defined by a documented DXA scan T-score of <=
-2.5 in the femoral neck of at least one hip within the last year. If no
documented T-score, then a DXA scan will be performed during eligibility
screening.
3. Subject has one hip without previous surgery or fracture.
4. Subject is medically stable from any previous treatment or medical procedure
in the opinion of the investigator and with an ASA score of I or II.
5. Subject has willingness, ability, and commitment to participate in baseline
and follow-up evaluations for the full length of the study.
6. Subject is capable of giving written informed consent to participate in the
study.
Exclusion criteria
1. Subject is less than six (6) months removed from having a hip fracture
repair or prosthesis, or less than three (3) months removed from an elective
THA.
2. Subject has progressive increase in undiagnosed hip pain over the previous
six months that in the opinion of the Investigator may suggest other underlying
bone or joint pathology (e.g. rheumatoid arthritis, fracture, etc.).
3. Subject is dependent on the use of a wheel-chair or is bed-ridden.
4. Subject has albumin corrected serum calcium levels outside the normal lab
range or has a pre-existing calcium metabolism disorder (e.g. hypercalcemia).
5. Subject has severe renal insufficiency defined as an estimated glomerular
filtration rate (eGFR) <= 30 mL/min or is being treated with dialysis.
6. Subject has insulin-dependent diabetes mellitus (IDDM).
7. Subject has Body Mass Index (BMI) > 35.
8. Subject exhibits excessive smokeless tobacco use or excessive smoking as
determined by the principal investigator*.
9. Subject exhibits excessive alcohol consumption as determined by the
principal investigator*.
10. Subject has radiological evidence of gross bony or joint pathology,
including signs predictive of atypical femoral fractures (e.g. Cortical
beaking) or has been diagnosed and/or treated for atypical femoral fractures.
11. Subject treated with corticosteroids or systemic glucocorticoids for ten
(10) days in the previous six (6) months.
12. Subject has history of oral or parenteral use of immune-suppressive drugs
in the previous twelve months.
13. Subject has history of metabolic bone disease other than osteoporosis (ex.
Paget*s disease).
14. Subject has a history of auto-immune arthritic diseases including
rheumatoid, psoriatic, or those associated with systemic lupus erythematosus,
spondyloarthropathy, Reiter*s Syndrome or Crohn*s Disease.
15. Subject has a history of radiation therapy to the hip or pelvic region.
16. Subject has a history of any invasive malignancy (except basal cell
carcinoma), unless treated and with no clinical signs of symptoms of malignancy
for five (5) years.
17. Subject has known allergies to implanted device.
18. Subject has severe comorbidity or poor general physical/mental health that,
in the opinion of the Investigator, will not allow the subject to be a good
study candidate.
19. Subject is currently enrolled in another clinical study.
*AgNovos*s recommendation is >1 pack per day smoking and >3 alcoholic drinks
per day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02916953 |
| CCMO | NL60420.068.17 |