Clinical Research Directory

Feasibility of a Mindfulness and Physical Activity Promotion Intervention After Anterior Cruciate Ligament Reconstruction

The goal of this clinical trial is to learn whether a 6-week mobile-delivered intervention combining mindfulness meditation (Headspace) and personalized, wearable-derived physical activity goals (Oura Ring) can be feasibly delivered to young people who are 1-5 years post-anterior cruciate ligament reconstruction (ACLR) and who have elevated fear of reinjury. The main questions it aims to answer are: * Can the Mind in Motion intervention be implemented with acceptable rates of recruitment, retention, engagement (mindfulness session completion, Oura Ring wear), and participant-rated acceptability? * On days following a completed mindfulness session, do participants report lower anticipated fear of movement and show higher objectively measured moderate-to-vigorous physical activity (MVPA), compared with other days? Participants will: * Complete two brief in-person visits (approximately 1 week apart) that frame a 6-week home-based intervention period, followed by a remote assessment 4 weeks after the intervention ends. * Wear a research-grade activPAL accelerometer on the thigh for 7 days before and 7 days after the intervention to measure objective physical activity. * During the 6-week intervention, complete five 10-minute Headspace mindfulness sessions per week, wear an Oura Ring daily to receive personalized daily activity goals, and complete brief twice-daily check-ins (ecological momentary assessments) about fear, mood, and activity. * Complete standard questionnaires about injury-related fear, psychological readiness for activity, and knee function/symptoms at baseline, mid-intervention, immediately after the intervention, and at a 4-week follow-up. * Complete a brief audio-recorded exit interview describing their experience with the intervention. This is a single-arm, single-site feasibility study; there is no control group and no randomization. Findings will inform the design of a future multisite randomized controlled trial.

Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction

Rehabilitation of knee stability and function after anterior cruciate ligament (ACL) reconstruction is slow and costly. The use of anabolic steroids, such as oxandrolone, may aid in the recovery of muscle mass and strength, as well as functional capacity. Oxandrolone, derived from dihydrotestosterone, has high anabolic activity and low androgenic activity (a 13:1 ratio), making it more effective in promoting weight gain with fewer side effects compared to other steroids. Registered by the FDA and previously by ANVISA, the National Health Surveillance Agency in Brazil, it is indicated for cases of post-trauma or post-surgery weight loss. The subdermal use of oxandrolone implants is proposed to release the drug directly into the bloodstream, improving efficacy and reducing issues related to oral administration. This study evaluates the safety and tolerability of the oxandrolone subdermal bioabsorbable implant for 24 weeks versus placebo implant in both men and women as an adjuvant treatment during rehabilitation following anterior cruciate ligament (ACL) surgical reconstruction. The serum and pharmacokinetic profile of the oxandrolone subdermal bioabsorbable implant will be monitored.

Comparison of Video Based Phone App vs. Supervised Preoperative Exercise for ACL Reconstruction

The goal of this clinical trial is to learn if using a phone app for exercises is as effective as working with a physical therapist before anterior cruciate ligament knee surgery. It will also check if exercising before surgery helps patients recover better compared to those who do not follow a specific exercise plan. The main questions it aims to answer are: * Does the phone app help patients improve their knee strength and movement as well as seeing a physical therapist? * Do patients who exercise before surgery have a better recovery after surgery than those who do not? Researchers will compare the phone app group to a physical therapist group and a group with no specific exercise plan to see which method works best. Participants will: * Follow an exercise plan for 4 weeks before their surgery (either using the app, with a therapist, or no specific plan). * Visit the clinic for check-ups before starting the exercises, right before the surgery, and 6 months after the surgery. * Complete simple tests and surveys to measure their knee health.

Use of Simplified Pain Questionnaire Among People Receiving Anterior Cruciate Ligament (ACL) Knee Surgery?

The goal of this randomized clinical trial is to compare opioid consumption among patients who receive a binary pain scale compared to those who receive a standard 10-point pain scale after undergoing anterior cruciate ligament (ACL) reconstruction surgery.

Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.

M-ARS ACL Post-marketing Surveillance Study

The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction. The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.