12 Clinical Trials for Various Conditions
The purpose of this study is to compare two different platelet-rich plasma (PRP) injections for patellar tendinosis. Aim: To perform a randomized, double blinded study comparing the clinical effect of PRP versus PRP + concentrated insulin-like growth factor (IGF) in patients with patellar tendinosis.
Blood flow restrictive (BFR) therapy following MPFL or ACL reconstruction rehabilitation. Specific Aim 1: Test whether maintaining BFR cuff inflation or deflating between exercises results in greater quadriceps strength and functional outcomes after MPFL or ACL reconstruction. Hypothesis 1: Subjects in the deflate BFR protocol group will have significantly greater quadriceps strength, symmetric leg symmetry index on a battery of functional tests and PROs as compared to the non-deflate group. Specific Aim 2: Compare whether maintaining BFR cuff inflation or deflating between exercises results in reduced pain, improved exercise tolerance, and patient-reports outcomes (PRO) after MPFL or ACL reconstruction. Hypothesis 2: Subjects in the deflated BFR protocol group will report significantly less pain and greater exercise tolerance during exercise with significantly improved knee related PRO scores.
Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.
The goal of this observational study is to learn about the outcomes of medial patellofemoral ligament (MPFL) reconstruction for the treatment of recurrent patellar instability. The main questions it aims to answer are: * What are the risk factors for recurrent patellar instability after MPFL reconstruction? * What functional outcomes do patients report after MPFL reconstruction? Participants undergoing MPFL reconstruction will answer survey questions about their knee and activity level 1 year and 2 years after surgery.
The goal of this observational study is to understand how diffusion tensor imaging (DTI) relates to other traditional measures and knee function. The main question it aims to answer is: Will regions of known patellar tendon pathology present with smaller DTI scalar parameters, shorter fiber length, and lower fiber density compared to the contralateral tendon and healthy regions in the ipsilateral tendon. Participants will: * undergo MRI and ultrasound imaging * perform knee function test * complete questionnaires
The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-55 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years.
The investigators plan to perform a prospective observational cohort study of patients undergoing MPFL reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. The investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.
Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community. Historically, nonoperative treatment for first time patella dislocation has been problematic due to high redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization, followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both soft tissue and boney realignment operations, have also had mixed results, including low success rates, associated complications, and variable rates of return to functional activity (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment. Methods/Design: This study is designed as a two arm randomized prospective trial. Approximately fifty subjects will be randomly assigned to either a surgical or non-operative arm by means of a computer randomized allocation program. All subjects will have X-Ray Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to determine if any excluding conditions exist. Subjects randomized to the surgical group will have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical therapy for approximately 12 weeks. Physical therapy will progress through five phases with the goal of gait normalization, full range of motion and return to sport. Both arms will be given outcome questionnaires and physical activity assessments before treatment, and at one, three, six, twelve, and twenty four month intervals. Discussion: This prospective randomized trial will investigate the results of direct repair of the medial patellofemoral ligament and conservative treatment by applying subjective outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and six months post trauma. Any reported recurrent dislocation or subluxation event will be documented during recovery. All subjects will receive merchant x-ray views at 3 months with manual lateral translation of the patella.
Platelet rich plasma has been used in previous studies to stimulate faster healing of torn ligaments and tendons in order to help reduce pain and restore normal function. This study aims to prove that non-operative treatment of acute and chronic ligament and tendon injuries with platelet rich plasma will reduce the time needed for participants to heal these injuries and restore function. We are currently enrolling patients with PATELLAR TENDON INJURIES in the KNEE.
Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction