Osteoporosis porous bone Osteoporosis
Conditions
Interventions
AGN1™ Local Osteo-Enhancement Procedure (LOEP®) Kit
Sponsors
AgNovos Healthcare USA, LLC
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
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 interview, 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: o Subject reports difficulty seeing o Lack of depth perception or vision loss in one eye o Macular degeneration o Cataractso Prior non-hip fragility fracture o Cognitive frailty as assessed by SPMSQ (mild cognitive impairment determined by SPMSQ with a score of = 4) or delirium o Parkinson’s disease stage 3 or 4 o 10-year hip fracture probability >15% using the FRAX® Fracture Risk Assessment Tool of the clinical site country4. Subject is ambulatory (with or without aids) prior to the hip fracture. “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
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, and/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 as defined by 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 score 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 the 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 7.4.2CIP Section 7.4.2. Subject Screening Pre-operative eligibility criteria The subject will be evaluated immediately before beginning the hip facture surgery by the orthopaedic surgeon and a physician anesthesiologist to agree on eligibility of the patient for randomization into the AGN1 LOEP Study. The subject will not be a candidate for the AGN1 LOEP Study if they have experienced any of the following changes or complications since initial study consent: • A change to an ASA Class of V or VI • Occurrence or relevant suspicion of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, unstable angina, pulmonary embolus, deep vein thrombosis, ventricular tachycardia, or atrial fibrillation) • Any complications or factors that in the judgement of the surgeon or the physician anesthesiologist disqualify the subject from receiving the elective AGN1 LOEP treatment Upon completing the hip fracture surgery and before randomization and beginning the AGN1 LOEP treatment, the subject will be re-evaluated by the orthopaedic surgeon and physician anesthesiologist. The surgeon and a physician anesthesiologist overseeing the cas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint: the cumulative incidence of secondary fragility hip fractures in the contralateral unfractured target hip in the Treated Group compared to the incidence in the Control Group. Primary safety evaluation: the incidence of all Adverse Events and all Serious Adverse Events in the Treated Group relative to the incidence in the Control Group until the primary efficacy endpoint is reached. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total hip areal bone mineral density (aBMD) in target hips of the Treated Group is significantly greater than that of the Control Group at 1 year for all subjects who have achieved 1 year of follow-up by the end of enrollment. 2. Total hip areal bone mineral density (aBMD) in target hips of the Treated Group is significantly greater than that of the Control Group at 2 years for all subjects who have achieved 2 years of follow-up by the end of enrollment. | — |
Countries
Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom
Contacts
Public ContactDP Plonski
AgNovos Healthcare USA, LLC
Outcome results
None listed