The study is for subjects that are undergoing knee surgery to repair and reconstruct the ligaments and tendons in the knee. Data will be collected to evaluate the continued safety and effectiveness of the screws and anchors that are used during the surgery to do the repair and reconstruction of the ligaments and tendons in the knee. There are six visits over a two-year time period that will be conducted during your standard of care visits with the doctor. During those visits outcome data will be collected via questionnaires. The study is designed to collect real world data from the general population on products that are cleared for sale in the U.S.
The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.
The goal of this randomized controlled trial is to analyze return to pre-injury activity level on subjects with lateral ankle instability undergoing a modified Broström reconstruction procedure for repair of the anterior talofibular ligament (ATFL). The subjects undergoing ATFL reconstructive procedure using the Artelon FLEXBAND® system as an augmentation device will be compared to subjects undergoing a standard modified Broström procedure alone. Artelon FLEXBAND is a commercially available, polycaprolactone (PCL) polyurethane urea (PUUR) multipolymer synthetic knitted mesh that is used for soft tissue reinforcement procedures. The device is biocompatible and degradable and has been used as an augmentation device in over 50,000 Orthopedic tendon and ligament reconstructive procedures. Artelon FLEXBAND has received its FDA 510(k) clearance. Enrollment is expected to take approximately 1 year. All subjects will be followed for 2 years post-operatively for a total study duration of approximately 3 years. Study follow-up visits will occur at 2-, 6-, 12-, 18- and 26-weeks, and 1- and 2-years after surgery. Possible, anticipated procedure-related risks associated with using the FLEXBAND device include, but are not limited to, infections, both deep and superficial, allergies or other reaction to device materials, dislocation, subluxation or inadequate scope of movement as a result of failure to achieve optimum positioning of the implant, bone fractures as a result of one-sided overload or weakened bone structure, temporary or permanent nerve damage as a result of pressure or hematoma, wound hematoma, and delayed wound healing. Benefits include improvement in function, including return to pre-injury activity levels.
Total ankle replacement has become an increasingly recommended treatment option for endstage ankle osteoarthritis over the last decades. As a result of this progress, a large variety of implant systems exist.
The Hintermann Series H3 Total Ankle Replacement System (H3) is a three-piece, mobile-bearing implant. The H3 is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease.
The purpose of this study is to investigate long-term (up to 5 years) how the H3 implant is performing, collect information about the device through x-rays of the joint, document any complications from the device implant, see how the device affects patient quality of life.
The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).
This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.
This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.
This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.
PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.
The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.