Fragility Fracture, Hip Fractures, Osteoporosis
Conditions
Keywords
Osteoporosis, Hip Fracture, Fragility Fracture, LOEP, RESTORE, Local osteo-enhancement procedure
Brief summary
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.
Detailed description
This is an event driven, randomized, controlled, prospective, single blinded (non-blinded in Canada), multi-national study. This study is designed to demonstrate that the AGN1 LOEP treatment can reduce the incidence of secondary hip fractures in subjects presenting with an index hip fracture and undergoing hip fracture repair surgery. Subjects presenting with an index fragility hip fracture who will undergo hip fracture repair will be enrolled. Subjects will be randomized 1:1 into the following two study groups: 1. Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip 2. Control Group - receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip AGN1 LOEP is an elective procedure that will be performed immediately following hip fracture repair. Subjects will be followed through scheduled visits conducted at 6 weeks, 6 months, and every 6 months thereafter for a minimum of 5 years.
Interventions
DEVICEAGN1 LOEP treatment
the implantation site is injected with the AGN1 implant material
Sponsors
AgNovos Healthcare, LLC
Avania
CMIC Co, Ltd. Japan
BioClinica, Inc.
Emergent Clinical Consulting, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 91 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is a postmenopausal female at least 1-year post menses and at least 65 years of age and less than 92 years of age. 2. Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip. 3. Subject has at least one of the following additional risk factors for a secondary hip fracture (as determined by subject or legally authorized representative (LAR) interview or medical record review): * Documented falls assessment indicating subject is at moderate or high risk of falls * Falls history (2 or more falls in the previous 12 months) * History of vertigo, dizziness, or postural hypotension * Documented T-score \< -2.5 at the hip * Taking more than 3 daily prescription medications * Visual impairment as confirmed by one of the following: * Subject reports difficulty seeing * Lack of depth perception or vision loss in one eye * Macular degeneration * Cataracts * Prior non-hip fragility fracture * Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ ≤ to 4) or delirium * Parkinson's disease stage 3 or 4 * 10-year hip fracture probability \>15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country 4. Subject is expected to be ambulatory after the hip fracture repair procedure. "Ambulatory" is defined as a patient's ability to ambulate beyond simple transfers with or without assistive devices. 5. Informed consent is provided by the subject or the subject's LAR. Use of an LAR to obtain patient consent requires that the patient must understand and be able to participate in post operative restrictions and requirements. 6. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full duration of the study has been documented.
Exclusion criteria
1. Criterion omitted 2. Criterion omitted 3. Subject is currently enrolled in another interventional clinical study affecting the target hip. 4. Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture. 5. Subject has new fractures in addition to the index hip fracture at admission that, in the opinion of the investigator, would further compromise patient mobility, rehabilitation, or recovery. 6. Subject has an infection at the LOEP intended treatment site or has non-intact skin or acute traumatic injuries with open wounds close to the area of intended LOEP treatment. 7. Subject has a progressive increase in undiagnosed pain in the target hip contralateral to the index fractured hip over the previous 3 months that in the opinion of the Investigator may suggest underlying bone or joint pathology on the unfractured side. 8. Subject has radiological evidence of gross bony or joint pathology of the hip, including signs predictive of atypical femoral fractures (e.g. cortical beaking), or has been diagnosed and/or treated for atypical femoral fractures. 9. Criterion omitted 10. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia). 11. Criterion omitted 12. Subject has active cancer 13. Criterion omitted 14. Criterion omitted 15. Criterion omitted 16. Criterion omitted 17. Criterion omitted 18. Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 15 mL/min. 19. Criterion omitted 20. Criterion omitted 21. Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher. 22. Subject has known allergies to calcium-based bone void fillers. 23. In the judgement of the Investigator, the subject is not a good study candidate (e.g., poor mental health, or active drug or alcohol abuse issues), and or subject would not be a good candidate to undergo an ELECTIVE orthopedic surgical procedure such as a total hip arthroplasty in her current medical, physiological condition. 24. Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of secondary fragility hip fractures | Interim Analysis, approximately 30 Months | Comparison of incidence of secondary fragility hip fractures in the target hip among the Treated Group vs. Control Group. |
| Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Interim Analysis, approximately 30 Months | Comparison of incidence of AEs and SAEs among the Treated Group vs. Control Group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Areal bone mineral density (aBMD) | 12 months and 24 months | Total hip areal bone mineral density in target hips of the Treated Group compared to the Control Group |
Countries
Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom
Contacts
CONTACTCharles Raymond
Outcome results
None listed