Clinical Research Studies

Florida Orthopaedic Associates is committed to offering our patients the latest developments in medicine, while at the same time providing our patients with the highest quality of patient care. One of the ways we accomplish this goal is through clinical trials offered through Florida Research Associates, LLC. Clinical trials, after all, are at the heart of all medical advances.

Below is a list of our current enrolling studies. Talk with your doctor, or ask to speak with Diane Martin, Clinical Research Manager and Coordinator, about volunteering to participate in a clinical trial.

Principal Investigator – Mark Hollmann, MD

Sub-Investigator – Henry Samsoe, RPA-C

Clinical Research Manger and Coordinator – Diane Martin, RN

Protocol: CR17-003

Phase: Post-Market

Device: Truliant Knee System

Sponsor: Exactech, Inc.

Description: Ten-year study to evaluate change from pre-operative baseline to post-operative TKA functional performance in patients who receive the Truliant Knee Implant System.

Stipend Provided to Patient: Yes

Protocol Number: 14022

Device: ATTUNE Cementless CR RP (cruciate retaining rotating platform) and ATTUNE Cementless PS RP (posterior stabilized rotating platform)

Sponsor: Medical Device Business Services, Inc.

Description: Five-year study to evaluate the change from pre-operative baseline to post-operative TKA functional performance improvement for the ATTUNE Cementless TKA RP System.

Stipend Provided to Patient: Yes

Protocol: DSJ-2016-03

Device: ATTUNE Revision TKA FB (fixed bearing) and RP (rotating platform) Tibial Platform with PS (posterior stabilized) Femoral Component

Sponsor: Medical Device Business Services, Inc.

Description: Five year study to evaluate change from pre-operative baseline to post-operative TKA functional performance in patients who have degrees of complexity that require the use of one or more ATTUNE revision components, typically to manage existing deformities, ligamentous deficiencies and bone loss.

Stipend Provided to Patient: Yes

Protocol: DSJ-2016-02

Device: ATTUNE Revision TKA FB (fixed bearing) and RP (rotating platform) Tibial Component with PS (posterior stabilized) Femoral Component

Sponsor:  Medical Device Business Services, Inc.

Description: Five-year study to evaluate change from pre-operative baseline to post-operative TKA functional performance in patients with a failed primary knee replacement, including unicompartmental arthroplasty and those with a failed prior revision TKA.

Stipend Provided to Patient: Yes

Protocol: 10008

Device: ATTUNE Primary TKA. CR FB (cruciate retaining fixed bearing), PS FB (posterior stabilized fixed bearing), CR RP (cruciate retaining rotating platform) and PS RP (posterior stabilized rotating platform)

Sponsor: Medical Device Business Services, Inc.

Description: A fifteen-year study to evaluate change from pre-operative baseline to post-operative TKA functional performance in patients with severely painful and/or severely disabled NIDJD (non-inflammatory degenerative joint disease) resulting from OA (osteoarthritis) or post-traumatic arthritis.

Stipend Provided to Patient: Yes

Protocol: BA058-05-021

Phase: 3

Study Medication: Abaloparatide-sMTS

Sponsor: Radius Health, Inc (RADIUS)

Description: Sixteen-month open label study to evaluate a comparison of abaloparatide-sMTS, a transdermal application to the thigh daily for 5 minutes, to abaloparatide-subcutaneous, an injection administered in the abdomen daily, for the treatment in postmenopausal women with osteoporosis.

Stipend Provided to Patient: Yes

Protocol: 62-180

Phase: Pivotal Study, IDE G140140

Status: Closed to enrollment and open to follow-up

Device: Spineology Interbody Fusion System (SIFS) Device – SIFS mesh is a graft containment and reinforcement device

Sponsor: Spineology, Inc.

Description: An FDA regulated study that follows subjects from pre-op to a maximum of 48-months post-op assessing for changes over time in subject pain, function and fusion and evaluates device safety.

Stipend Provided to Patient: Yes

ClinicalTrials.gov Identifier:  NCT02347410

Protocol: EN3835-210

Medication: EN3835 (XIAFLEX) injection versus a placebo injection (1:1 ratio)

Indication: Unilateral Frozen Shoulder (Adhesive Capsulitis of the Shoulder)

Sponsor: Endo Pharmaceuticals, Inc.

Description: Study patients must be > 18 years of age, diagnosed with idiopathic unilateral adhesive capsulitis, able to undergo MRIs of both shoulders and are able to speak, read and understand English. MRIs of both shoulders, x-ray of affected shoulder, EKG, and labs will be performed as part of study eligibility at no cost to the patient. Eligible patients will receive up to 3 study treatment injections with standard home exercises (required to maintain a diary for compliance) and in-office PT sessions between injection treatments. Patients will be evaluated for shoulder ROM, frozen shoulder severity, function and pain at subsequent visits up to Day 95 (End of Study).

Stipend Provided to Patient: Yes