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RecruitingNot ApplicableNCT04796350

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

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

Sponsor

AgNovos Healthcare, LLC

Enrollment

2,400 participants

Start Date

Apr 24, 2021

Study Type

INTERVENTIONAL

Conditions

OsteoporosisHip FracturesFragility Fracture

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.

Eligibility

Sex: FEMALEMin Age: 65 YearsMax Age: 91 Years

Plain Language Summary

Simplified for easier understanding

The RESTORE study is testing a procedure called LOEP (Low-Intensity Pulsed Ultrasound or a related local energy procedure) on the unfractured hip of postmenopausal women aged 65 or older who have just broken one hip (the index fracture). A second hip fracture in the year following the first is one of the most devastating and common complications in older women, often resulting in permanent disability or death. This study aims to see whether treating the 'good' hip proactively can reduce the risk of a second fracture. Participants are women who just had a low-energy hip fracture, are undergoing surgical repair, and have additional risk factors for falling or fracturing again. The procedure is applied to the unfractured hip during the hospital admission. Long-term follow-up tracks whether the treated women have fewer secondary hip fractures. You may be eligible if... - You are a postmenopausal woman aged 65 or older - You have just had a low-energy fragility hip fracture and will undergo surgical repair - You have at least one additional fracture risk factor (fall history, low bone density, vision impairment, cognitive frailty, Parkinson's, or high FRAX score) - You are expected to walk again after surgery You may NOT be eligible if... - You were admitted to hospital more than 24 hours after the fracture - You were wheelchair-bound or bedridden before the fracture - You have already had surgery on the unfractured (target) hip or a previous fracture there - You have active cancer (within the last 5 years, except non-melanoma skin cancer) - You have severe heart failure (NYHA Class III/IV) or a pacemaker - You have had a cardiovascular event (stroke, heart attack, DVT, PE) in the last 3 months - You have severe kidney disease (eGFR ≤ 30) - You have severe cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAGN1 LOEP treatment

the implantation site is injected with the AGN1 implant material

Locations(66)

Innsbruck Hospital

Innsbruck, Austria

Ziekenhuis Oost-Limburg

Genk, Belgium

Ghent University Hospital

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Vitaz Sint-Niklaas

Sint-Niklaas, Belgium

Health Sciences Centre - Eastern Health

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Sunnybrook Health Sciences Centre

North York, Ontario, Canada

Aarhus University Hospital

Aarhus, Denmark

CHU de Nice

Nice, Provence-Alpes-Côte d'Azur Region, France

CHU Amiens

Amiens, France

CHU Grenoble-Alpes

Grenoble, France

CHU Lyon

Lyon, France

CHU Toulouse

Toulouse, France

Charite University Hosptial

Berlin, Germany

University Hospital of Duesseldorf

Düsseldorf, Germany

Justus Liebig Universitat Gießen

Giessen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Germany

Klinikum der Universität München

München, Germany

University Hospital of Münster

Münster, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

BG Klinik Tuebingen

Tübingen, Germany

Helios Wuppertal

Wuppertal, Germany

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

ASST Gaetano Pini CTO

Milan, Italy

University Hospital San Raffaele Milano

Milan, Italy

Policlinico Tor Vergata

Rome, Italy

CTO Torino

Torino, Italy

Akita City Hospital

Akita, Akita, Japan

Southern Tohoku General Hospital

Kōriyama, Fukushima, Japan

Hyogo Prefectural Nishinomiya Hospital

Nishinomiya, Hyōgo, Japan

Kagawa Rosai Hospital

Marugame, Kagawa-ken, Japan

Kanto Rosai Hospital

Kawasaki, Kanagawa, Japan

Chikamori Hospital

Kochi, Kochi, Japan

Okayama Medical Center

Okayama, Okayama-ken, Japan

Jutendo University Shizuoka Hospital

Izunokuni, Shizuoka, Japan

The University of Tokyo Hospital

Bunkyō-Ku, Tokyo, Japan

St. Mary's Hospital

Fukuoka, Japan

Iwata City Hospital

Iwata, Japan

Shin-Yurigaoka General Hospital

Kawasaki-shi, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Japan

Saga-Ken Medical Centre Koseikan

Saga, Japan

Japanese Red Cross Shizuoka Hospital

Shizuoka, Japan

Deventer Hospital

Deventer, Netherlands

Saint Anna Ziekenhuis

Geldrop, Netherlands

Maastricht UMC

Maastricht, Netherlands

Isala Hospital

Zwolle, Netherlands

Vall d'Hebron University Hospital

Barcelona, Barcelona, Spain

Valladolid University Clinic Hospital

Valladolid, Valladolid, Spain

Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de Basurto

Bilbao, Spain

Galdakao-Usansolo Hospital

Galdakao, Spain

Hospital Neuro-Traumatológico de Jaén

Jaén, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Infanta Leonor

Madrid, Spain

Hospital St Joan de Deu

Manresa, Spain

PARC Tauli

Sabadell, Spain

Mutua de Terrassa University Hospital

Terrassa, Spain

Birmingham Heartlands Hospital

Birmingham, England, United Kingdom

Leicester Royal Infirmary

Leicester, England, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Queen Elizabeth Glasgow

Glasgow, United Kingdom

Wythenshawe Hospital Manchester

Manchester, United Kingdom

Nottingham University Hospitals, Queen's Medical Center

Nottingham, United Kingdom

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