RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Официальное название

Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство AGN1 LOEP treatment
  the implantation site is injected with the AGN1 implant material

Первичные конечные точки

• Cumulative incidence of secondary fragility hip fractures [Срок оценки: Interim Analysis, approximately 30 Months]
• Cumulative Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Interim Analysis, approximately 30 Months]

Вторичные конечные точки (1)

• Areal bone mineral density (aBMD) [Срок оценки: 12 months and 24 months]

Критерии участия

Критерии включения

• 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.
• Subject presents with a low-energy index fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
• 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
• 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.
• 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.
• 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.

Критерии исключения

• Criterion omitted
• Criterion omitted
• Subject is currently enrolled in another interventional clinical study affecting the target hip.
• Subject has a history of hip surgery or previous hip fracture on the target unfractured hip contralateral to the index hip fracture.
• 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.
• 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.
• 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.
• 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.
• Criterion omitted
• Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
• Criterion omitted
• Subject has active cancer
• Criterion omitted
• Criterion omitted
• Criterion omitted
• Criterion omitted
• Criterion omitted
• Subject has end stage renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 15 mL/min.
• Criterion omitted
• Criterion omitted
• Subject has moderate or severe cognitive impairment as assessed by an SPMSQ of 5 or higher.
• Subject has known allergies to calcium-based bone void fillers.
• 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.
• Subject fails pre-operative or intraoperative eligibility criteria as specified in section 7.4.2. of the clinical investigation plan.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Япония · 15 центров

• Akita City Hospital — Akita
• Southern Tohoku General Hospital — Kōriyama
• Hyogo Prefectural Nishinomiya Hospital — Nishinomiya
• Kagawa Rosai Hospital — Marugame
• Kanto Rosai Hospital — Kawasaki
• Chikamori Hospital — Kochi
• Okayama Medical Center — Okayama
• Jutendo University Shizuoka Hospital — Izunokuni
• … и ещё 7 центров

Испания · 12 центров

• Vall d'Hebron University Hospital — Barcelona
• Valladolid University Clinic Hospital — Valladolid
• Clinic de Barcelona — Barcelona
• Hospital Universitario de Basurto — Bilbao
• Galdakao-Usansolo Hospital — Galdakao
• Hospital Neuro-Traumatológico de Jaén — Jaén
• Hospital Clínico San Carlos — Madrid
• Hospital Universitario 12 de Octubre — Madrid
• … и ещё 4 центра

Германия · 10 центров

• Charite University Hosptial — Berlin
• University Hospital of Duesseldorf — Düsseldorf
• Justus Liebig Universitat Gießen — Giessen
• Medizinische Hochschule Hannover — Hanover
• Universitatsklinikum Schleswig-Holstein — Kiel
• Klinikum der Universität München — München
• University Hospital of Münster — Münster
• Universitätsklinikum Regensburg — Regensburg
• … и ещё 2 центра

Великобритания · 6 центров

• Birmingham Heartlands Hospital — Birmingham
• Leicester Royal Infirmary — Leicester
• Royal Infirmary of Edinburgh — Edinburgh
• Queen Elizabeth Glasgow — Glasgow
• Wythenshawe Hospital Manchester — Manchester
• Nottingham University Hospitals, Queen's Medical Center — Nottingham

Франция · 5 центров

• CHU de Nice — Nice
• CHU Amiens — Amiens
• CHU Grenoble-Alpes — Grenoble
• CHU Lyon — Lyon
• CHU Toulouse — Toulouse

Италия · 5 центров

• Azienda Ospedaliero Universitaria Careggi — Florence
• ASST Gaetano Pini CTO — Milan
• University Hospital San Raffaele Milano — Milan
• Policlinico Tor Vergata — Rome
• CTO Torino — Torino

Бельгия · 4 центра

• Ziekenhuis Oost-Limburg — Genk
• Ghent University Hospital — Ghent
• UZ Leuven — Leuven
• Vitaz Sint-Niklaas — Sint-Niklaas

Нидерланды · 4 центра

• Deventer Hospital — Deventer
• Saint Anna Ziekenhuis — Geldrop
• Maastricht UMC — Maastricht
• Isala Hospital — Zwolle

Канада · 3 центра

• Health Sciences Centre - Eastern Health — St. John's
• QEII Health Sciences Centre — Halifax
• Sunnybrook Health Sciences Centre — North York

Австрия · 1 центр

• Innsbruck Hospital — Innsbruck

Дания · 1 центр

• Aarhus University Hospital — Aarhus

Идентификаторы

NCT: NCT04796350 · AGN-CIP-100 / AGN-CIP-100-CA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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