Periprosthetic Joint InfectionsMAGICNCT05361941
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
A study testing EP Granules with Tobramycin and empty voids in people with Periprosthetic Joint Infections, run by Elute, Inc. at 16 sites in United States.
Trial 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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, in the 1st stage of a staged revision… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periprosthetic Joint Infections
- What is being tested?
- EP Granules with Tobramycin and empty voids
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 16 sitesUnited States
- Study dates
- 31 Aug 2023to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 13 recruiting
- Recruiting
U Michigan Medical Center
Ann Arbor, Michigan, 48109
Justin Quimbo, 734-232-4145, quimbo@med.umich.edu
Michael Kheir, MD
- Recruiting
Sinai Hospital
Baltimore, Maryland, 21215
Makayla Crosby, 410-601-2663, mcrosby@lifebridgehealth.org
Nate Helwig, 410-601-8434, nhelwig@lifebridgehealth.org
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Completed
Brigham & Womens Hospital
Boston, Massachusetts, 02115
- Recruiting
Carrollton regional Medical Center
Carrollton, Texas, 75010
Angela Mealing, 469-443-0924, mealing@dallaslimbrestoration.com
Richard Buch, MD
- Recruiting
OrthoCarolina
Charlotte, North Carolina, 28204
Justin Norwood, 704-323-3845, justin.norwood@orthocarolina.com
Josef Jollisaint, MD
- Recruiting
JIS Orthopedics
Columbus, Ohio, 43054
Michael Sneller, 614-964-0348, snellerma@jisortho.com
David Crawford, MD
- Withdrawn
Sanford South University Medical Center
Fargo, North Dakota, 58103
- Recruiting
OrthoIndy
Indianapolis, Indiana, 46278
Melanie Glover, 317-802-2880, mglover@orthoindy.com
Christopher Pomeroy, MD
- Recruiting
University of Southern California
Los Angeles, California, 90033
Pui Yan, puiyan@med.usc.edu
Nathanael Heckmann, MD, 800-872-2273, nathanael.heckmann@med.usc.edu
- Withdrawn
West Virginia University Medical Center
Morgantown, West Virginia, 26506
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Amar Ranawat, MD, 212-606-1000, ranawatamar@hss.edu
Alberto Carli, MD
- Recruiting
UT Health San Antonio
San Antonio, Texas, 78229
Jhemima Rizalde, 210-567-6176, rizalde@uthscsa.edu
Frank Buttacavoli, MD
- Recruiting
Endeavor Health Skokie Hospital
Skokie, Illinois, 60076
John Carroll, 847-933-6328, jcarroll@northshore.org
Hristo Piponov, MD
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Joshua Lawrence, 240-863-1681, joshua.lawrence@medstar.net
Brett Levine, MD
- Recruiting
Jordan Valley Medical Center
West Jordan, Utah, 84088
David Evans, MD, (801) 891-5056, dcevans1@gmail.com
About this study
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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, 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).
Read the detailed description
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study to demonstrate superiority of new bone growth and a reduction in recurring infections, and thereby improve outcomes for patients undergoing a staged revision for periprosthetic joint infections (PJIs).
The standard of care for treatment of PJIs typically involves either a 2-stage revision or 1.5 stage revision which entails loss of bone stock resulting from debridement of infected bone in Stage 1. In the Stage 2 procedure, surgeons use metal cones to make up for this bone loss and better support the revision implant. Inadequate bone growth could result in gaps at the the voids below the level of the cortical bone, resulting in regions with no contact with the revision implant or cement mantle. Such gaps could result in dead-space regions, and zones without new bone growth required to support the revision implant. Both deficiencies affect long-term survival of the revision implant.
The study has two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of the staged surgical treatment, and a control arm where subjects are treated with the standard-of-care staged surgical treatment for infected PJIs.
Outcomes are demonstration of new bone growth and reduction of recurrent infections.
- Conditions
- Periprosthetic Joint Infections
- Being tested
- EP Granules with Tobramycin, empty voids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP Granules with TobramycinDevice
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.
empty voidsDevice
Voids are left empty
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: empty voids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 24 months after stage 1 surgery
Secondary outcomes (2)
Secondary outcome: patient reported quality of life.
SF-12 or PROMIS -10 score
Measured: 12 months after stage 1 surgery
Secondary outcome: AKSS Score
- AKSS Pain and Function Scores
Measured: 12 months after stage 1 surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start31 Aug 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprosthetic Joint InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elute, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bruce Evans, MD, Study chair, Holy Cross Jordan Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361941
- Sponsor's protocol ID
- TP-001-21
- Acronym
- MAGIC
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2022
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
- ClinicalTrials.gov ID
- NCT05361941
- Acronym / sponsor ID
- MAGIC / TP-001-21
- Conditions
- Periprosthetic Joint Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Elute, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, 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).
Detailed description
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study to demonstrate superiority of new bone growth and a reduction in recurring infections, and thereby improve outcomes for patients undergoing a staged revision for periprosthetic joint infections (PJIs).
The standard of care for treatment of PJIs typically involves either a 2-stage revision or 1.5 stage revision which entails loss of bone stock resulting from debridement of infected bone in Stage 1. In the Stage 2 procedure, surgeons use metal cones to make up for this bone loss and better support the revision implant. Inadequate bone growth could result in gaps at the the voids below the level of the cortical bone, resulting in regions with no contact with the revision implant or cement mantle. Such gaps could result in dead-space regions, and zones without new bone growth required to support the revision implant. Both deficiencies affect long-term survival of the revision implant.
The study has two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of the staged surgical treatment, and a control arm where subjects are treated with the standard-of-care staged surgical treatment for infected PJIs.
Outcomes are demonstration of new bone growth and reduction of recurrent infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: EP Granules with TobramycinThe 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. |
| Control Arm | Active comparator | Device: empty voidsIn 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Severe renal impairment with eGFR <50 ml/min/1.73 m2, or being treated with dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP Granules with TobramycinEP 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. | Device | Treatment Arm |
| empty voidsVoids are left empty | Device | Control Arm |
Primary outcome
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
Time frame: 24 months after stage 1 surgery
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.
Absence of serious device related adverse events requiring re- operation
Time frame: 24 months after stage 1 surgery
A serious device related adverse event requiring re-operation * Success = no adverse event occurs * Failure = adverse event occurs
2 secondary outcomes
Secondary outcome: patient reported quality of life.
Time frame: 12 months after stage 1 surgery
Secondary outcome: AKSS Score
Time frame: 12 months after stage 1 surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Periprosthetic Joint Infections
Recruiting
Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Prosthetic Joint Infection of Knee
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
Impact of Nutritional Status Before Joint Replacement on Infection Risk
Periprosthetic Joint Infection (PJI), Malnutitrion
RecruitingPhase 1/2
A Phase 1/2 Study to Evaluate the Safety, PK and Efficacy of TNP-2092 Administered Via IA Injection in PJI Participants
Periprosthetic Joint Infection (PJI)
Enrolling by invitationPhase 3
Or v IV Antibiotics for Infection
Joint Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Evans, MD study chair
Holy Cross Jordan Valley Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EP Granules with Tobramycin and empty voids in people with Periprosthetic Joint Infections, run by Elute, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashok Khandkar, PhD (801-410-4330, ak@elutinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events. (time frame: 24 months after stage 1 surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.