Treatment Trials

92 Clinical Trials for Various Conditions

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RECRUITING
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Description

The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are: * Is the intervention feasible and acceptable to patients? * Does the intervention result in a decrease in opioid dose during the preoperative period? Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.

COMPLETED
Supporting Decision Making for Musculoskeletal Preference-Sensitive Care
Description

The purpose of this study is to compare condition oriented whole person Health Coaching along with the provision of decision aids to decision aids without condition oriented Health Coaching to neither condition oriented health coaching nor decision aids on medical cost, preference sensitive surgeries and measures of subject knowledge, decision process and decision quality.

RECRUITING
MDR - PMCF Study for Echo FX Stem With RingLoc Bipolar Acetabular Cup and Femoral Head
Description

The objective of this retrospective enrollment and prospective follow-up study is to confirm safety, performance, and clinical benefits of the Echo FX Stem with the RingLoc Bipolar Acetabular Cup and Femoral Head in hip hemiarthroplasty (implants and instrumentation) at a minimum of 10 years follow-up. All available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

UNKNOWN
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
Description

This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. They will see a physical therapist in a physical therapy office after their surgery. Here, the therapist will work with the patient to strengthen muscles and improve their walking. The second group, the "Self-directed Physical Therapy" group, will undergo physical therapy in the comfort of their own home using common household items (chairs, steps, etc). These patients will be given a list of exercises and stretches to perform on their own. It is our goal to prove that formal physical therapy is not needed after anterior hip replacements.

RECRUITING
MDR - PMCF Study for Taperloc Complete Stems
Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.

COMPLETED
Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
Description

This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.

Conditions
UNKNOWN
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
Description

This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections

COMPLETED
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty
Description

The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral, obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is to determine whether FICB can reduce postoperative pain and increase progress with physical therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial will randomize patients to receive either a FICB or placebo after THA. The primary outcomes will be pain scores reported by the patient post-operatively.

RECRUITING
G7 Acetabular System with Vivacit-E or Longevity Liner PMCF Study
Description

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

COMPLETED
Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial
Description

Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.

NOT_YET_RECRUITING
Psychosocial Interventions for Young Adults With Hip Pain
Description

Psychosocial conditions are common in young adults with hip pain including depression, anxiety, pain catastrophizing, and narcotic use. The incidence of these conditions is not well defined. Interventions to optimize psychosocial conditions with non-surgical or surgical treatments has not been investigated. The goal of this project is to determine the incidence of psychosocial conditions in the young adult population with hip pain and determine if cognitive based therapy can improve clinical outcomes in these individuals.

TERMINATED
MDR - M/L Taper With Kinectiv Technology Stems and Necks
Description

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the M/L Taper with Kinectiv Technology Stems and Necks when used for primary or revision total hip arthroplasty (implants) at 1,2,5 and 10-year follow-up\*. ML Taper with Kinectiv Technology has been on the market since 2008, but has insufficient long term clinical data. Therefore, a prospective aspect to the study will be necessary to reach the 10-year time point.

COMPLETED
An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
Description

The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy. This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.

COMPLETED
Preoperative Pain Threshold and Rapid Recover Programs
Description

To investigate the association between grip strength and preoperative pain threshold as measured by pressure algometer and validated pain outcome surveys.

COMPLETED
TXA vs. Amicar in Total Knee and Hip Arthroplasty
Description

The purpose of this study is to determine the relative effectiveness of two drug agents, Tranexamic acid (TXA) and aminocaproic acid (Amicar), that act through a similar mechanism of action. These agents are used to decrease blood loss that is a result of major surgery, like total joint arthroplasty. A secondary goal will be investigate the cost-analysis of total hospitalization. Both TXA and Amicar are both currently used in the care of patients undergoing total joint arthroplasty. Subjects will be randomly assigned to the TXA or Amicar arm. All data needed for this study including blood loss, need for transfusion, preoperative and lowest postoperative hematocrit and hemoglobin, and complications will be collected during the hospitalization stay. Our Hypothesis is that TXA and Amicar will have similar effectiveness in preventing intraoperative blood loss and the need for transfusion post-op than Amicar. A detailed cost analysis will show that the overall cost of performing the operative procedure, including transfusions, OR time, and total costs associated with admission cost will be more decreased with Amicar as compared to TXA.

TERMINATED
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Description

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

UNKNOWN
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA
Description

The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.

UNKNOWN
Long-Term Multi-center Evaluation of E-Poly and Regenerex
Description

There are two distinct aims of this study: 1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene. 2. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.

COMPLETED
Navigator vs Standard Needle Injection for Hip
Description

The purpose of this randomized, parallel-group, single-blinded, single center, Phase II study is to collect data to compare the comfort and patient satisfaction of a hip injection delivered via the Navigator compared to a standard needle injection. In addition, delivery preparation will be compared between a Navigator injection and a standard hip injection. The data collected from this pilot study will serve as the basis to design a larger multi-center study.

COMPLETED
A Clinical Investigation of the Taperloc® Microplasty™ Hip System
Description

The purpose of this prospective clinical data-collection is to document the performance and clinical outcomes of the Taperloc® Microplasty™ Hip System.

COMPLETED
A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement
Description

The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

COMPLETED
A Clinical Investigation of the C2a-Taper™ Acetabular System
Description

The objective of this study is to gather clinical and survivorship information for the C2a-Taper™ Acetabular System, a ceramic-on-ceramic hip articulating system.

COMPLETED
Addressing Patients' Expectations of Total Hip Arthroplasty in a Randomized Trial
Description

The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total hip arthroplasty.

SUSPENDED
A Validated Necrosis Assay to Determine the Need for Revision Surgery in Metal-on-metal Total Hip Arthroplasty
Description

The purpose of the study is to develop a biomarker assay to be used as a diagnostic tool for adverse local tissue reaction, or tissue necrosis, in a metal on metal total hip replacement. A convenience sample of a total of 100 hip patients will be enrolled: 50 metal-on-metal revision hips, 25 metal-on-poly revision hips, and 25 pre-operative total hips (no implant, control group) will be enrolled. Preoperative blood serum samples and intraoperative synovial fluid will be obtained from all hips and used for biomarker testing. Additionally, intraoperative assessment of tissue necrosis will be assessed.

COMPLETED
Understanding the Differences in the Management of Patients With Arthritis of the Knee or Hip
Description

The purpose of this study is to examine cultural and clinical context factors in African-American and white veterans with knee or hip osteoarthritis with a focus on how these factors may be potentially modifiable determinants of willingness to consider joint replacement.

NOT_YET_RECRUITING
EMPHASYS Cup Position in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Description

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

ENROLLING_BY_INVITATION
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
Description

A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets.

COMPLETED
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound
Description

The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).

RECRUITING
Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
Description

In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.

COMPLETED
Meditation and Opioid Consumption in Total Joint Replacement Patients Undergo Primary Total Hip and Knee Replacement
Description

The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.