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STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

Primary Purpose

Hip Fractures, Osteoporosis, Postmenopausal

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

AGN1 Femoral Local Osteo-Enhancement Procedure Kit

About this trial

This is an interventional treatment trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject is a postmenopausal female
Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip.
Subject is ≥ 65 years of age.
Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study.
Subject is capable of giving written informed consent to participate in the study.

Exclusion Criteria:

Subject has a prior diagnosis of secondary osteoporosis.
Subject has history of any hip surgery or previous hip fracture in the non-fractured hip.
Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.).
Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges.
Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges.
Subject has insulin-dependent diabetes mellitus (IDDM).
Subject has Body Mass Index (BMI) > 30.
Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*.
Subject exhibits excessive alcohol consumption as determined by the principal investigator*.
Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip.
Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months.
Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months.
Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease).
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.
Subject has a history of radiation therapy to the hip or pelvic region.
Subject has history of chemotherapy treatment for any condition within the previous five years.
Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years.
Subject has known allergies to implanted device.
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.
Subject is currently enrolled in another clinical study.

Sites / Locations

Queen Mary Hospital - Department of Orthopaedics and Traumatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

AGN1 Treatment

Arm Description

Subjects who have suffered a fragility hip fracture in one hip, sign the consent form and meet the inclusion and none of the exclusion of the study will receive the AGN1 Femoral Local Osteo-Enhancement Procedure (LOEP™) in the non-fractured hip.

Outcomes

Primary Outcome Measures

Incidence of Treatment or Device Emergent Serious Adverse Events

Incidence of all serious adverse events (SAEs) occurring from the day of procedure through the twenty-four (24) month follow-up period determined to be definitely related to Femoral LOEP and/or the AGN1 device.

Secondary Outcome Measures

Incidence of Non-Treatment Emergent Fragility Fractures

Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period.

Incidence of Treatment or Device Emergent Adverse Events

Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.

Change in Bone Mineral Density between Baseline and 12 Months

Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months.

Change in Bone Mineral Density between Baseline and 24 Months

Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months.

Full Information

NCT ID

NCT03268356

First Posted

August 29, 2017

Last Updated

November 28, 2022

Sponsor

AgNovos Healthcare, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03268356

Brief Title

STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

Official Title

Clinical Investigation of a Local Osteo-Enhancement Procedure's (LOEP) Ability to Strengthen the Contralateral Femur of Women After a Fragility Fracture of the Hip in Hong Kong

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

August 15, 2017 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AgNovos Healthcare, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the procedure and safety profile of the AGN1 Femoral LOEP Kit. This pilot study will be used to evaluate AGN1 Femoral LOEP treatment in a contralateral proximal femur during hip fracture repair.

Detailed Description

The research will be conducted as a prospective single-center study within Hong Kong. The maximum number of subjects to be treated is twenty (20). This will be a non-randomized and non-blinded study. Subjects having had a fragility hip fracture on one side will be treated with LOEP in the contralateral non-fractured proximal femur in the same operative session as the surgical repair of the fractured hip. A fragility fracture is defined as a fracture resulting from a fall from standing height. All subjects will undergo hip fracture repair as recommended by the treating orthopedic surgeon. Repair may include nailing, plates, screws and hip prosthesis. Subjects may continue to receive, or when appropriate, can be commenced on a treatment regime for osteoporosis. This decision will be made by the treating physician who will determine the best course of action for each patient. The outcome of this decision will have not affect the patient's eligibility for this trial. Follow-up visits will be conducted at three (3) months, six (6) months, twelve (12) months, and twenty-four (24) months after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Fractures, Osteoporosis, Postmenopausal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AGN1 Treatment

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

AGN1 Femoral Local Osteo-Enhancement Procedure Kit

Other Intervention Name(s)

AGN1 Femoral LOEP™

Intervention Description

A procedure that is intended to replace lost bone and increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck.

Primary Outcome Measure Information:

Title

Incidence of Treatment or Device Emergent Serious Adverse Events

Description

Time Frame

24 Months

Secondary Outcome Measure Information:

Title

Incidence of Non-Treatment Emergent Fragility Fractures

Description

Incidence of fragility fractures unrelated to the device or procedure occurring during the follow-up period.

Time Frame

24 Months

Title

Incidence of Treatment or Device Emergent Adverse Events

Description

Incidence of all adverse events occurring from the day of procedure through the twenty-four (24) month follow-up determined to be definitely related to Femoral LOEP and/or the AGN1 device.

Time Frame

24 Months

Title

Change in Bone Mineral Density between Baseline and 12 Months

Description

Evaluation of bone mineral density (BMD) post-procedure at twelve (12) months.

Time Frame

12 Months

Title

Change in Bone Mineral Density between Baseline and 24 Months

Description

Evaluation of bone mineral density (BMD) post-procedure at twenty-four (24) months.

Time Frame

24 Months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is a postmenopausal female Subject has a low-energy fragility hip fracture in one hip and will undergo surgical repair of the fractured hip. Subject is ≥ 65 years of age. Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study. Subject is capable of giving written informed consent to participate in the study. Exclusion Criteria: Subject has a prior diagnosis of secondary osteoporosis. Subject has history of any hip surgery or previous hip fracture in the non-fractured hip. Subject has progressive increase in undiagnosed hip pain over the previous six (6) months that in the opinion of the Investigator may suggest other underlying bone or joint pathology (e.g. osteoarthritis, fracture, etc.). Subject has serum calcium levels outside the normal lab range as per local guidelines and reference ranges. Subject has moderate to severe renal insufficiency as per local guidelines and reference ranges. Subject has insulin-dependent diabetes mellitus (IDDM). Subject has Body Mass Index (BMI) > 30. Subject exhibits excessive smokeless tobacco use or excessive smoking as determined by the principal investigator*. Subject exhibits excessive alcohol consumption as determined by the principal investigator*. Subject has radiological evidence of gross bony or joint pathology of the non-fractured hip. Subject treated with corticosteroids or systemic glucocorticoids for ten (10) days in the previous six (6) months. Subject has history of oral or parenteral use of immune-suppressive drugs in the previous twelve months. Subject has history of metabolic bone disease other than osteoporosis (eg. Paget's disease). 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. Subject has a history of radiation therapy to the hip or pelvic region. Subject has history of chemotherapy treatment for any condition within the previous five years. Subject has history of any diagnosis and treatment of malignancies (excluding basal cell carcinoma) within the previous five years. Subject has known allergies to implanted device. 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. Subject is currently enrolled in another clinical study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Fang, MD

Organizational Affiliation

Queen Mary Hospital, Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital - Department of Orthopaedics and Traumatology

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.agnovos.com

Description

Company website

Learn more about this trial

STRONG - Study of AGN1 LOEP for the Treatment of the Contralateral Femur After Fragility Fracture

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