Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities

NCT05361941 | Recruiting DMC FDA Device

• 1 other identifier: TP-001-21
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 12

Brief Summary

This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs).

Conditions

Periprosthetic Joint Infections

Outcome Measures

Primary Outcomes (2)

• A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.

  A\] New bone growth observed in voids at 12 months versus pre-op stage 1 and B\] Absence of infection at 24 months versus pre-op stage 1 surgery.

  24 months after stage 1 surgery

• Absence of serious device related adverse events requiring re- operation

  A serious device related adverse event requiring re-operation * Success = no adverse event occurs * Failure = adverse event occurs

  24 months after stage 1 surgery

Secondary Outcomes (2)

• Secondary outcome: patient reported quality of life.

  12 months after stage 1 surgery

• Secondary outcome: AKSS Score

  12 months after stage 1 surgery

Study Arms (2)

Treatment Arm

EXPERIMENTAL

The device will be placed in voids at Stage 1. This will be followed by IV therapy for about six weeks, followed by assessment of infection, with a stage 2 surgery to follow. (For 1.5-stage, stage 2 procedure is optional). During the stage 2 surgery, the surgeon completes the procedure with affixing the revision implants.

Device: EP Granules with Tobramycin

Control Arm

ACTIVE COMPARATOR

In the standard of care arm, voids are left empty and a bone cement spacer placed during stage 1 surgery. This is followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the spacer is removed and procedure completed by affixing the revision implants. For 1.5-stage procedures, the stage 2 procedure is optional.

Device: empty voids

Interventions

EP Granules with Tobramycin DEVICE

EP Granules with Tobramycin is a Ca-salt resorbable intended for orthopedic applications as a bone void filler for bone gaps or voids and in cases where risk of post-operative infection is high, such as the first stage of a 2-stage or 1.5 stage revision of an infected total joint.

Treatment Arm

empty voids DEVICE

Voids are left empty

Control Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages and sexes eligible: at least 22 years, male and female
• Candidates with known infected TKA
• Life expectancy of at least 1 year
• Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
• Adequate soft tissue coverage
• Signed institutional review board approved informed consent

You may not qualify if:

• Severe renal impairment with eGFR \<50 ml/min/1.73 m2, or being treated with dialysis
• Known hypersensitivity to aminoglycoside antibiotics, or calcium hydroxyapatite
• Pre-existing calcium metabolism disorder
• Uncontrolled diabetes mellitus (hemoglobin A1c levels \> 8)
• A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroid parathyroid hormone disorder, Ehler- Danlos syndrome, osteogenesis imperfecta)
• Neuromuscular disorders such as myasthenia gravis
• Untreated malignant neoplasm(s), or currently undergoing radiation chemotherapy
• Inadequate neurovascular status in the involved limb that may jeopardize healing
• HIV
• Pregnancy
• Adult patients requiring a legal guardian to sign informed consent form

Sponsors & Collaborators

• Elute, Inc.: lead

Study Sites (12)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Endeavor Health Skokie Hospital

Skokie, Illinois, 60076, United States

RECRUITING

OrthoIndy

Indianapolis, Indiana, 46278, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Brigham & Womens Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

U Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Hospital for Special Surgery

New York, New York, 10021, United States

RECRUITING

Sanford South University Medical Center

Fargo, North Dakota, 58103, United States

RECRUITING

JIS Orthopedics

Columbus, Ohio, 43054, United States

RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Jordan Valley Medical Center

West Jordan, Utah, 84088, United States

RECRUITING

West Virginia University Medical Center

Morgantown, West Virginia, 26506, United States

RECRUITING

Study Officials

• Bruce Evans, MD

  Holy Cross Jordan Valley Hospital

  STUDY CHAIR

Central Study Contacts

Ashok Khandkar, PhD

CONTACT

801-410-4330; ak@elutinc.com

Eva Serio, BS

CONTACT

801-410-4330; eva@elutinc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 5, 2022
• Study Start: August 31, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)