Treatment Trials

11 Clinical Trials for Various Conditions

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RECRUITING
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Description

Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.

COMPLETED
Optional Follow-up Visits for Common, Low-risk Arm Fractures
Description

Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments. Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not. Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.

TERMINATED
Chlorhexidine and/or Betadine Prep in Pediatric Arm Surgery Following Trauma
Description

There have been numerous studies demonstrating surgical site infections that arise from contamination at time of surgery or by seeding from other sites in the body which arise from organisms normally found on the skin. This has been known to cause complications in spine surgery, shoulder, hip, and knee arthroplasty. While studies have shown that organisms like Cutibacterium persists on the skin despite standard surgical preparation, there have not been studies that examine the organisms found in the fingernail region pre- and post- standard surgical preparations. This study investigates how thorough fingernails are prepped prior to the operation. The results of this study would determine whether providers are adequately cleaning the patient's entire arm, including under the fingernail, prior to surgery. The results may support continuation of the current practice or adding to the standard surgical preparation to ensure adequately sterilization of surgical sites and all exposed areas, which include the fingernails.

COMPLETED
CT Imaging Evaluation of Humerus Fractures
Description

Displaced, multi-part intracapsular, proximal humerus fractures represent a major challenge for patients and orthopedic surgeons. Proximal humerus fractures represent the third most common fracture after hip and distal radius fractures, and more than 20% of these fractures meet operative indications. Unfortunately, one of the major complications of these fractures is the development of avascular necrosis (AVN), or death of the bone as a result of the loss of blood supply to it. Currently, the ability to predict AVN is limited. The purpose of this study is to determine if computed tomography imaging can identify a quantifiable predictor of AVN following this type of humeral fracture.

COMPLETED
Is Univalving or Bivalving of Long Arm Casts for Forearm Fractures Necessary?
Description

This study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.

COMPLETED
Exparel for Postoperative Pain Management in Shoulder Surgery
Description

The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

TERMINATED
Well-arm Exercise in Distal Radius Fractures
Description

A single center randomized control study. Patients \>18 years with isolated distal radius fractures treated non-operatively will be randomly assigned to either the treatment group (exercise of contralateral "well" arm) or control group (standard fracture care and rehabilitation).

RECRUITING
KT Tape for Pediatric Clavicle Fractures
Description

Clavicle fractures in children are mostly managed non-operatively since they have an overall high union rate (95%) and a "good" functional outcome following nonoperative treatment. However, the downside of such a conservative approach is that patients have to live with pain and disability until the fracture heals. To minimize this, fractures are usually immobilized with a sling. There have been no studies looking at clavicle fractures treated with kinesiology (elastic) tape. No adverse effects (skin irritation, redness, etc.) are observed with the application of this tape. Elastic tape has previously been examined regarding muscular advantages rather than for healing fractures. Since this tape should immobilize fractures better than a sling, patients should experience less pain and disability associated with their fracture.

WITHDRAWN
Long Arm Vs Short Arm Fiberglass Cast for Treatment of Displaced Distal Radius Fractures
Description

The aim of the study is to determine by multicenter randomized controlled trial whether short arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric distal third forearm fractures that have undergone closed reduction. The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction, or surgical intervention. Secondary outcomes will include Patient Reported Outcome Measures for physical function, such as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper Extremities , and UCLA (University of California Los Angelos) Activity Scale, and pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns etc). The investigators will assess potential risk factors for loss of reduction including initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial translation, initial angulation, age, sex, cast index, padding index, adequacy of initial reduction, and provider level of training.

WITHDRAWN
Long-Arm vs Sugar-Tong
Description

The purpose of this study is to determine whether a sugar-tong splint is as effective as a long-arm cast in maintaining reduction of pediatric forearm shaft fractures in a randomized, prospective manner. Consented participants will be randomly assigned to be treated with either a sugar-tong splint or a long-arm cast (both standard of care treatments) in REDCap. Each participant will have a 50/50 chance of being assign to either treatment.

WITHDRAWN
Randomized Trial With an Observational Component of Non-operative Versus Operative Treatment for AO Type A3 Fractures
Description

The purpose of this study is to compare surgery plus bracing versus bracing alone. Both groups are considered standard of care treatments. The goal of this study is to determine which group is a better treatment.