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Clinical Trials: Muscle, Bone and Cartilage
IRB No. 07-016-1 (Dr. Martin Freilich, PI): Osteoporosis and bone augmentation/implant outcomes: An observational study
The objective of this study is to utilize a clinical study model to collect descriptive data needed to support the development of future studies that will test the association between specific measures of bone health and the successful integration of new bone from bone augmentation procedures. Postmenopausal women with a wide range of bone health and reduced jaw bone thickness will receive bone augmentation therapy followed by implant and restoration placement, with the specific treatment based upon best clinical judgment. Throughout initial diagnosis, treatment and follow-up, blood makrers will be drawn to assess bone health and its possible association with treatment outcomes. Outcomes will be based upon clinical and radiographic examination, bone health markers and patient interviews.
IRB No. 06-577-2 (Dr. Augustus Mazzocca, PI): Proximal Humerus and Distal Femur Intramedullary Aspiration During Standard Rotator Cuff or ACL Repair: A Pilot Study.
Study description not available
IRB No. 10-051-3 (Dr. Thomas Taylor, PI): Short-implants – An Alternative To Bone Grafting
The purpose of this trial is to compare two techniques for implant placement into the posterior upper jaw. One technique involves bone grafting and the use of larger implants (11, 13 or 15 mm implants); the other will invoke the of a very short implant (6 mm) and thus avoid the need of bone grafting of the sinus. The primary objective is to compare implant survival rate. Secondary objectives are to evaluate: marginal bone level (MBL) alterations; condition of periimplant mucosa, crown-to-implant ratio; the resource us and costs assoctiated with the treatments; Oral Health Impact Profile (OHIP); and safety by recording of Adverse Events (AEs) and Adverse Devise Effects (ADEs).
IRB No. 11-151-2 (Dr. Vincent Williams, PI): Hip and Knee Outcome Registry
Patients that have their hip or knees replaced by Dr. Williams or Dr. Lindsay have the option to enroll in the registry.
IRB No. 13-060-3 (Dr. Bruce Liang, PI): A Novel Biomarker for Diagnosing and Quantifying Skeletal Injury
Study description not available
IRB No. 13-099-3 (Dr. George Kuchel, PI): Embryonic and pluripotent stem cell-produced factors as novel therapeutic candidates for improved aged muscle function and regenerative responses in humans
Study description not available
IRB No. 14-136-6 (Dr. Biree Andemariam, PI): Hemoglobinopathies and Bone Health
This research study has two purposes. The first purpose is to determine whether having sickle cell trait is a risk factor for the development of bone thinning at an earlier age than expected. Nearly 10% of African Americans carry sickle cell trait and most of them are unaware of it. African Americans are less likely to develop thin bones than whites, but if they sustain a bone fracture, they are more likely to die from it. We believe having sickle cell trait may lead to bone thinning and predispose a subset of African Americans to dangerously thin bones. The second purpose is to try to understand why individuals with sickle cell disease have thinner bones than healthy individuals do. Doctors have already discovered that people with sickle cell disease have very thin bones, but they have not determined why. Our study will try to identify whether the bone thinning is from the body not making enough bone or from the body losing bone once it is made.
IRB No. 17-014-3 (Dr. Robert Arciero, PI): Mid- and Long-Term Outcomes for Patients Treated with High Tibial Osteotomy
This study will examine the outcomes of patients who underwent a high tibial osteotomy (HTO, or realignment of the knee by cutting the tibia) performed by Dr. Robert A. Arciero at least two years ago for multiple indications. A survey will be used to collect postoperative outcome information from patients regarding current pain, satisfaction and functional outcomes. A chart review will be conducted to collect information regarding demographics, preoperative clinical factors, radiographs and the HTO procedure. Preoperative, operative and postoperative factors will be examined to determine which factors relate to positive outcomes.
IRB No. 17-066-3 (Dr. Augustus Mazzocca, PI): Factors Influencing Successful Non-operative Management of Patients with Acromioclavicular Joint Dislocations
This study will examine the outcomes of patients who had an acromioclavicular (AC) joint dislocation at least two years ago and were initially treated without surgery by Dr. Augustus Mazzocca. A survey will be used to collect updated post-treatment outcome information from patients regarding the current condition, symptoms and functioning of the injured shoulder. A chart review will be conducted to collect demographic and clinical information including injury, treatment and, where applicable, intra-operative details. Retrospective and prospective data will be examined to determine the factors associated with positive outcomes.
IRB No. 17-070-1 (Dr. Robert Arciero, PI): Mid and Long Term Outcomes of Anterior Shoulder Instability after Arthroscopic Stabilization
The purpose of this study is to assess outcomes at 5 years or more in patients who have undergone an arthroscopic stabilization for symptomatic unidirectional anterior shoulder instability. A survey will be used to collect updated postoperative outcome information from patients regarding current pain, satisfaction and functional outcomes. A chart review will be conducted to collect demographic, injury and perioperative details. These factors will be combined to examine correlations with outcomes.
IRB No. 17-124-3 (Dr. Robert Arciero, PI): Mid and Long-Term Outcomes for Patients Treated with Distal Femoral Osteotomy
This study will examine the outcomes of patients who underwent distal femoral osteotomy surgery performed by Robert A. Arciero, MD and Thomas M. DeBerardino, MD at least two years ago. This knowledge may help to improve the treatment and outcomes of future patients who experience knee malalignment. A survey will be used to collect postoperative outcome information regarding current pain, satisfaction and functional outcomes. A chart review will be conducted to collect information regarding demographics, preoperative clinical factors, radiographs and the DFO procedure. Preoperative, operative and postoperative factors will be examined to determine which factors relate to positive outcomes.