51 Clinical Trials for Various Conditions
The purpose of this study is to help determine if a static stretching brace in addition to physical therapy decreases the incidence of secondary operations, increases range of motion, and individual patient function.
The purpose of this study is to determine the efficacy of ultrasound in diagnosing the presence or absence of extremity fractures or dislocations. Hypothesis: Can ultrasound be used as an accurate and effective method for determining the presence or absence of extremity fractures or dislocations? Is there a difference in amount of pain experienced prior to and after the ultrasound?
There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).
There is no consensus regarding whether rehabilitation or surgical stabilization leads to optimized outcomes for treatment of primary anterior shoulder dislocations. This prospective, randomized controlled trial therefore aims to compare arthroscopic Bankart repair versus physical therapy for the treatment of primary anterior shoulder dislocations.
Do teen-age patients with a dislocated knee cap do better with or without a brace?
This study compares intra-articular lidocaine to procedural sedation for the reduction of anterior shoulder dislocations in the emergency department.
The purpose of this study is to identify predictors of future injury and disability following LPD. The investigators' long term goal is to improve longitudinal outcomes of athletes with LPD following surgical and non-surgical management. Currently, there is limited information available to clinicians regarding appropriate criteria for returning athletes to sports participation following LPD. The evidence produced by this study will provide necessary information to develop appropriate rehabilitation strategies that may reduce the risk for future patellar instability and associated patellofemoral joint dysfunction and pain.
This randomized controlled trial will compare proximal femoral resection-interposition arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary outcome is quality of life and care giver burden measured by The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function (mobility questions), complications and surgical parameters such as OR time and fluoroscopy time. A cost-effectiveness analysis will follow completion of the randomized controlled trial (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the cost of the plate, longer operative time, longer length of stay, and blood loss, but Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better functional and quality of life outcomes.The results of this study are expected to improve outcomes for children with cerebral palsy with painful irreducible dislocated hips.
The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.
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.
To compare and validate the two clinical algorithms
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
The purpose of this project is to evaluate the effect of the Compass™ Universal Hinge external fixator on the outcome of patients following acute dislocation of the knee
The primary objective of this research is to examine the result of rotator cuff repairs following acute shoulder dislocations and to investigate whether timing of surgery following acute shoulder dislocations affects patients perception of pain, function, and strength following surgery.
The Lisfranc ligaments are a group of ligaments that connect the bones of the middle portion of the foot to each other. The Lisfranc ligaments allow for a normal and stable range of motion and shape to the foot. In certain foot fractures where the Lisfranc ligaments are damaged, the constraint and stability it had given to the middle of the foot is lost. Attempted activity at the foot will result in pain and abnormal motion. If injury to the Lisfranc ligaments is left untreated, the eventual end result is foot arthritis and deformity. The current standard orthopaedic treatment of foot fractures with Lisfranc ligament injuries is surgery. The foot fractures are fixed with metal screws. The Lisfranc ligaments are fixed by compressing the space between the middle bones of the foot with steel screws. These screws allow for ligament healing. As the ligaments heal, the patient should not resume activity with the fixed foot too soon as the screw may break. Upon breakage, the ligament repair may fail and the screw is now difficult to surgically remove. Regardless of breakage, a second surgical procedure is often recommended to remove the steel screw 6 months after foot surgery. This allows for a complete return of normal foot range of motion, but at the cost of a second surgical procedure. The investigators hypothesize that absorbable screw fixation of the 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.
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.
Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses: The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone and its effect on shoulder function and patient outcomes in military cadets recovering from shoulder stabilization surgery. We hypothesize after 6 weeks of BFR training will contribute to 13 (76%) or more participants will achieve scores within one standard deviation of normative values for isometric strength and functional tests at six months following shoulder stabilization surgery. Furthermore, we hypothesize that 14 (82%) or more participants will report improved patientreported outcomes as determined by the minimal clinical difference (MCD) at 12 weeks and six months post-operatively. Objective 1: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder isometric strength, as measured by a digital handheld dynamotor following shoulder stabilization surgery in military cadets. Objective 2: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder range of motion, as measured by a digital inclinometer, following shoulder stabilization surgery in military cadets. Objective 3: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder function as measured by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Seated Shot-Put Test (SSPT), and Upper Quarter Y-Balance Test (UQYBT), following shoulder stabilization surgery in military cadets. Objective 4: To evaluate the effectiveness of BFR training on shoulder pain, measured by a numerical pain rating scale, following shoulder stabilization surgery in military cadets. Objective 5: To evaluate the effectiveness of a BFR training on patient-reported outcomes, measured by Single Assessment Numeric Evaluation (SANE), Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder and Hand (DASH) following shoulder stabilization surgery in military cadets. Aim 1:To identify whether BFR with Physical Therapy is more effective at increasing shoulder strength than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder strength than the Physical Therapy group without BFR following shoulder stabilization surgery. Aim 2:To identify whether BFR with Physical Therapy is more effective at increasing shoulder function than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder function than the Physical Therapy group without BFR following shoulder stabilization surgery.
The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.
The purpose of this study is to prospectively determine whether intra-operative factors, complications and post-operative outcomes differ between beach chair and lateral decubitus surgical positioning for patients receiving arthroscopic shoulder stabilization (anterior or posterior) due to shoulder instability.
The purpose of the study is to determine if using ultrasound to diagnosis and confirm reductions of shoulder dislocations impacts the length of an emergency department visit for this condition.
This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss.
This research study is designed to allow health care professionals and researchers to answer many questions about whether a new type of physical therapy called blood flow restriction training (called BFRT) will improve recovery for those with patellar instability.
The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.
The purpose of this study is to investigate effects of timing of surgery (early vs. delayed) and timing of post-operative rehabilitation (early vs. delayed) for the treatment of military personnel and civilians that sustain a multiple ligament knee injury. To achieve this overall objective of this project, we will conduct two parallel randomized clinical trials. For the first study we will randomize individuals to timing of surgery and timing of post-operative rehabilitation. We hypothesize that early surgery, early rehabilitation and the combination of early surgery with early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports and better patient-reported physical function. In the second study, those whose timing of surgery can not be randomized, will be only randomized to early or delayed rehabilitation. For this study, we hypothesize that early rehabilitation will lead to an earlier and more complete return to pre-injury military duty, work and sports activity and better patient-reported physical function.
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.
To evaluate patient function, radiographic changes and complication rates of acute coracoclavicular (CC) joint reconstruction with and without the use of tendon graft as an augmentation to repair.
This study is a randomized controlled trial using Duke patients to test, compared to the standard of care, a questionnaire and statistical model used to determine how patient preference regarding shoulder pain, physical limitations, physical therapy, recovery period, prognosis, and cost impact choice of surgical versus non-surgical intervention. Phase 1 of this study is the initial testing of the instrument and involves a small group of up to 10 individuals who will partake in one-on-one interviews while completing the Shoulder Injury Survey to provide feedback. In Phase 2 of this study, 200 subjects will be randomized to receive either the Decision Tool or the standard Information on Shoulder Dislocation
The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.
The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.