11 Clinical Trials for Various Conditions
The objective of this study is to gather clinical data on SI-LOK® for the treatment of sacroiliac joint dysfunction. The purpose of this prospective study is to evaluate clinical and radiographic outcomes, intra-operative parameters, patient satisfaction and work status following a procedure using SI-LOK® for treatment of sacroiliac joint dysfunction with a minimum of three screws.
Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product. Up to 200 participants will be treated in this study at (up to) 15 clinical sites. Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol.
Comminuted intra-articular distal tibia fractures (OTA 43-C) typically are the result of high-energy trauma such as motor vehicle collisions or fall from a height. They are complex injuries often associated with significant fragment displacement and severe soft tissue injury, a combination that has long challenged orthopedic surgeons. Traditionally, surgeons use plain film (X-ray) and CT scans (2 or 3 dimensional) to determine fracture pattern and displacement. Yet, in some cases, it is still difficult to identify the relationship among bone fragments, which often makes articular restoration challenging. As a result, patients with non-anatomic joint reconstructions have a higher rate of poor outcomes. The primary objective of this study will be to compare patient outcomes in two groups, one group who will receive enhanced pre-operative planning (3D printed plastic prototype + standard of care \[SOC\] imaging with 3D CT scan + plain film radiographs) and a second group who will receive pre-operative planning using SOC imaging alone (3D CT scan + plain film radiographs only). Patient outcomes collected throughout the 12 month post-operative period will include an assessment of radiographic fracture healing (union, non-union, malunion), pain using a Numeric Pain Rating Scale, Olerud and Molander Score based on patient's self-report, and development of complications (infection, wound healing, re-operation, and re-hospitalizations). The secondary objective of this study will be to evaluate whether utilizing an enhanced pre-operative plan with a 3D printed plastic prototype altered the original pre-operative plan based on SOC imaging alone (3D CT scan + plain film radiographs only).
The goal of this clinical trial is to compare two types of surgical fixation in patients with specific kinds of distal femur fractures. The main questions it aims to answer is which operation for distal femur fractures is better for efficient return to work and everyday activities.
To determine the safety and efficacy of concomitant sacral fracture fixation and sacroiliac (SI) joint fusion vs. non-surgical management for patients with debilitating sacral fragility or insufficiency fractures
Thumb carpometacarpal (CMC) arthritis affect 1 in 4 females and 1 in 12 males. Patients who fail to respond to conservative treatment may benefit from surgery; however, controversy exists over the most effective surgical technique. A popular technique, ligament reconstruction with tendon interposition (LRTI) involves a trapeziectomy, followed by reconstruction of the palmar oblique ligament using a harvested flexor tendon from the wrist. We believe that use of a suture fixation system to reconstruct the palmar oblique ligament, instead of harvesting a wrist tendon, may provide a superior repair. The objective of this study is to compare functional outcome measurements among patients who receive CMC arthroplasty using a suture fixation system (investigational group) to those who receive LRTI surgery (control group). We hypothesize that patients in the investigational group will demonstrate superior functionality, compared to patients in the control group.
I hypothesize that absorbable screw fixation of the foot's Lisfranc ligaments does not yield significant differences in postoperative foot stability, ligament function, and symptoms when compared to steel screw fixation. In addition, absorbable screw fixation of the Lisfranc ligaments offers the advantage that a second surgical procedure to remove the screw is not necessary.
This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures. It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.
The purpose of the study is to determine whether surgical hemostats can minimize blood loss, need for allogeneic blood transfusions and their associated risks, and costs in patients with certain acetabular fractures requiring operative fixation via a non-extensile Kocher-Langenbeck surgical approach. Since surgical hemostats and other topical agents like platelet gel products have also been linked with improved wound healing, incidence of wound dehiscence and/or infections will also be examined. The investigators primary hypothesis is the topical hemostat will result in lower blood losses intraoperatively and fewer units of perioperative blood product transfused.
The objective of the registry is to evaluate the continued safety and performance of the Arthrex foot and ankle products including the ProStop implant for hyperpronated foot, Bio-Compression Screw for reconstruction surgeries of the foot, TRIM-IT Drill Pin, TRIM-IT Spin Pin for fixation of fractures and fusion (bunionectomy osteotomies) of the foot/ankle, Headless Compression Screws and Compression FT Screws for fixation of small bone fragments of the foot/ankle and DynaNite® Nitinol Staple to be used for fixation such as Lisfranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus and Beveled Headed FT Screws for osteotomy fixation of Hallux valgus repair (such as Scarf and Chevron etc.)
The purpose of this study is to determine the clinical efficacy of a novel sustained dynamic compression intramedullary nail for tibiotalocalcaneal (TTC) arthrodesis utilizing longitudinal weight-bearing computed tomographic imaging. Of particular focus will be assessment of compressive element recovery and its relation to fusion development over time and weight-bearing status. Additionally, the study will incorporate longitudinal fusion assessment to evaluate differences between three-dimensional weight-bearing computed tomography (WBCT) scans and two-dimensional radiographs (X-rays) at multiple points of the fusion process. Finally, the study will evaluate the differences in WBCT-based fusion assessment between automated and manual methodologies for fusion area calculation.