Clinical Research Directory

Efficacy and Safety of Celecoxib/Acetaminophen Versus Celecoxib for Diagnosed Osteoarthritis in Acute Exacerbation

This is a Phase III, longitudinal, multicenter, randomized, double-blind clinical trial designed to evaluate the efficacy and safety of a fixed-dose combination of celecoxib and acetaminophen compared to celecoxib monotherapy for the treatment of pain associated with acute exacerbations of osteoarthritis.

Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions

Clinical validation of SMARTDIAGO, an artificial intelligence-based system for remote functional assessment of patients with musculoskeletal disorders and functional frailty. The study will compare remote assessments performed using SMARTDIAGO with standardized in-person clinical evaluations to determine diagnostic accuracy, agreement, and operational feasibility.

Z1 Hip System: Post-Market Clinical Follow Up Study

The objectives of this study are to confirm the early to mid- term safety, performance, and clinical benefits of the Z1 Femoral Hip System in hemi- and primary total hip arthroplasty. Cohort 0 The primary endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure. The secondary endpoints are defined by the functional performance and clinical benefits of the study device and are assessed by patient-reported clinical outcomes measures (PROMs)(Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)). Cohort 1 The primary performance endpoint is the assessment of the HOOS JR, specifically the within-patient change from baseline to 2-years post-op. The mean change from baseline will be compared against a minimal clinically important difference (MCID) of 9.46 points. The key secondary safety endpoint is defined by the survival of the implant system at 2 years, which is based on the absence of removal of the study device and will be evaluated using a one-sample proportion as well as using the Kaplan Meier method. The safety of the system will additionally be assessed by monitoring the frequency and incidence of adverse events, including relation to implant, instrumentation, and/or procedure. Exploratory outcomes include: * EuroQol 5 Dimensions (EQ-5D) * Patient Satisfaction * Radiographic outcomes, where available

Multicentre SMS Study - FR

Prospective, multicentre, non controled, non randomised, clinical study to assess the performance and the stability of SMS femoral stem

MDR - G7 Neutral and G7 Freedom Constrained Neutral Acetabular Liners

The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.

Positioning for Hip Arthroscopic Surgery to Reduce Postoperative Numbness

Compared to the knee and shoulder, the hip joint leaves relatively little space to maneuver arthroscopic instruments and camera. To expand the potential space in the hip joint, traction is commonly applied to the operative leg through a perineal post. This is an effective technique to improve the working space for arthroscopy, however it has been associated with complications, including perineal numbness. Traction pads, used alone or with a perineal post, can reduce pressure on the perineal area, thus reducing numbness. The investigators hypothesize that positioning hip arthroscopy patients using a traction pad on a standard traction table with a perineal post will reduce the incidence and duration of postoperative perineal numbness.

MOVE-HIP: Ceramic Hip Resurfacing Versus Total Hip Arthroplasty Using Activity Monitoring

MOVE-HIP is a pragmatic, multicenter randomized clinical trial comparing ceramic hip resurfacing arthroplasty with contemporary total hip arthroplasty in adults with symptomatic hip osteoarthritis who are considered clinically eligible for both procedures. Participants in the randomized cohort are allocated 1:1 to either ceramic hip resurfacing or total hip arthroplasty and are kept blinded to treatment allocation where feasible through the 24-month primary follow-up. The primary objective is to determine whether ceramic hip resurfacing results in greater objectively measured mean daily walking distance over the postoperative period from 3 to 24 months. Activity is assessed during standardized 7-day wearable monitoring periods at 3, 12, and 24 months. The primary estimand is the adjusted overall between-group difference across these postoperative time points. A parallel observational preference cohort may include otherwise eligible patients who decline randomization; this cohort is analyzed separately and does not contribute to the primary randomized inference.

What Matters to Patients With Severe Hip or Knee Osteoarthritis?

This clinical trial aims to investigate if shared decision-making, and the use of an in-consultation patient decision aid (PtDA), increases the decisional quality and therefore treatment satisfaction and outcome of patients with severe hip or knee osteoarthritis. Finally, an evaluation will be conducted on patient-reported outcomes on pain, physical function, quality of life (QoL), and patient satisfaction, up to one year after surgery.

Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial

The DART Study is a prospective, multicentre observational cohort study evaluating day-case pathways for patients undergoing primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty at three hospitals in Møre og Romsdal, Norway (Volda, Ålesund and SNR). All patients scheduled for these procedures will be screened for eligibility for same-day discharge using predefined clinical, functional, and logistical criteria. The primary objective is to determine the proportion of patients who are discharged on the day of surgery. Secondary objectives are to assess recovery, pain, complications, emergency department visits, readmissions, reoperations, and mortality during the first 30 days after surgery. Patient-reported outcomes, including quality of recovery, joint-specific function, quality of life, pain, and awareness of the joint replacement, will be assessed before surgery and during follow-up for up to three months. Clinical and patient-reported data will be collected prospectively. Outcomes for patients discharged on the day of surgery will be compared with those of patients who remain in hospital overnight or longer. The study aims to evaluate the feasibility, safety, and patient experience of implementing standardized day-case hip and knee arthroplasty pathways within routine clinical practice.

Postoperative Analgesia in Hip Arthroplasty

The goal of this clinical trial is to compare the analgesic effectiveness of two blocks in hip arthroplasty. The main question it aims to answer is -Which block is more efficient? Researchers will compare the suprainguinal fascia iliaca block with the pericapsular nerve group block. Participants will be randomized, and one of the blocks will be applied.

Assessing the Time-Course of Dexmedetomidine-Induced Analgesia Via EEG

Objective: To investigate the temporal dynamics of dexmedetomidine's analgesic effects in the brain using EEG. Methods: Eligible patients scheduled for total hip arthroplasty under intrathecal anesthesia received a continuous infusion of DEX at 1.5 μg/(kg·h) for 15 minutes before neuraxial puncture, followed by an additional 15-minute infusion. The study was divided into three phases: Phase 1: Non-dosing phase (Baseline). Phase 2: DEX preemptive analgesia phase (DEX infusion). Phase 3: DEX cessation phase (Post-infusion). Outcomes: Primary safety outcome: EEG spectral analysis at different phases. Secondary outcomes: NRS scores, postoperative nausea and vomiting (PONV), dizziness, agitation, and time to intestinal exhaust within 48 hours. Intraoperative hemodynamics were also monitored.

Adapting Rehabilitation Delivery for Maximum Impact at Home-2 (ReDI-2)

People who live in rural areas and have hip or knee arthritis can have difficulty receiving physical therapy (PT) close to home. Living with hip or knee arthritis can make doing daily activities and being physically active difficult. This can lead to other health conditions, such as becoming overweight, or lessen enjoyment of life. We will compare 2 programs that allow physical therapists to treat rural residents in their own home to each other and to usual care. Usual care is the care that is typically provided to people living with hip or knee arthritis. For the first 12 weeks, participants will continue usual osteoarthritis (OA) care and then complete the standardized questionnaires again. Then, they will be randomized to either Individual (IPT) or Group-based PT (GPT). Over 12-weeks, therapists will meet virtually with patients using Zoom so that patients and therapists can see each other. The program will be either a class or one-on-one with a therapist. In the class, participants will still receive private one-to-one time with the therapist using a Zoom 'breakout' room. Therapists in both groups will help patients do exercises correctly in their home. Patients can also see and talk to the therapists to discuss their challenges in living with OA and set personalized goals including pain management, participating in valued daily activities, keeping healthy (diet, sleep) and being active. Both programs will allow patients who sometimes cannot access physical therapy to receive care in their home.

Bone Marrow Aspirate Concentrate Versus Triamcinolone Injection For Hip Osteoarthritis

This is a single site, randomized single blinded, two arm study researching the effects of bone marrow aspirate concentrate (BMAC) versus Triamcinolone in patients with hip osteoarthritis. The aims and hypothesis are as follows: Specific Aim 1: Evaluate the change in pain and functional scores of a single bone marrow aspirate injection in comparison to triamcinolone in patients with hip osteoarthritis through validated patient reported outcomes scores at baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that triamcinolone and BMAC groups will have pain reduction after each respective intervention. The changes with triamcinolone will be noticeable on the short term. The BMAC changes will take longer to have an effect but will longer duration. The investigators hypothesize that at 6 months and 1 year participants receiving BMAC will have better scores reported on the WOMAC compared to the triamcinolone injection and better than prior to injection. Specific Aim 2: Evaluate the change of bone marrow aspirate injection in comparison to triamcinolone in participant's performance on the 6 minute walk test from baseline to 12 months (6 weeks, 3 months, 6 months, and 12 months). Hypothesis: The investigators hypothesize that there will be higher walking distances on the 6 minute walk test in the participants receiving a BMAC injection in comparison to triamcinolone starting at the 3 months follow-up time. Specific Aim 3: Quantify and correlate cell characterization with patient reported outcomes score. Hypothesis: The investigators hypothesize that there will be better patient reported outcomes in patients who have a higher concentration of mesenchymal stem cells injected. The investigators will enroll 50 patients into each arm. Bone marrow will be aspirated then subsequently concentrated using the Emcyte PureBMC kit. The investigators will test the BMAC viability, rapid sterility, platelet concentration, volume, and total nucleated cell counts prior to injecting. The BMAC will be utilized as a hip injection into the affected hip of the patient. Patients receiving the Triamcinolone will undergo a sham bone needling to simulate the aspiration to keep patients blinded. Both groups will receive their injections under ultrasound guidance.

Can Pre-operative Anemia be Timely Identified and Optimized in Patients Awaiting Primary Arthroplasty Surgery? A Randomized Clinical Trial

Reducing the occurrence of anemia (low circulating hemoglobin levels) post-surgery has been associated with improved outcome, as it reduces complications and allows for faster return to pre-operative function. Post-operative hemoglobin level is dependent upon its pre-operative value (for a given amount of blood loss). About 17% of patients at the Ottawa Hospital (TOH), will be anemic pre-operatively, and if left untreated the patients will have significantly inferior outcomes compared to non-anemic patients. In order to improve outcomes, when a patient is identified as anemic, typically at the pre-operative assessment clinic, he/she is invited to be reviewed and optimized at the Pre-operative Blood Optimization Clinic (PBOC). However, only a quarter of anemic patients are seen in the PBOC due to the lack of time available between anemia identification and surgery and the current resources available. This project will focus on hemoglobin level optimization of pre-operative hip and knee, primary, arthroplasty patients to demonstrate whether early assessment and treatment of pre-operative anemia can be successfully integrated into practice and its impact on post-operative outcomes. Patients will be randomly assigned to either the current standard of care pathway with an anemia test at the pre-operative assessment clinic (2-4 weeks before surgery), at which time they have the option to seek treatment. Patients who are randomly selected to be in the experimental group, will undergo a test to detect anemia at the time they consent for surgery, which is usually 4-6 months prior to surgery. Patients with anemia, will be invited for treatment at the blood optimization clinic at this time. In doing so, this project will test whether timely identification and simple measures is feasible and whether such practice can reduce the overall anemia burden and ultimately improve patient outcome.

Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain

To prospectively describe patient-centered and health utilization outcomes through 12 months after cryoneurolysis performed as routine clinical care for chronic pain at Yale.

Progressive Resistance Training Versus Total Hip Arthroplasty in Patients With Hip Osteoarthritis

Hip osteoarthritis is associated with joint pain, physical disability, decreased muscle strength and poor health status, and the most common cause for total hip arthroplasty. No studies have investigated the effect of total hip arthroplasty compared to non-surgical treatment in patients with end-stage hip osteoarthritis. This comparison is of upmost importance as it is unknown whether non-surgical treatment may be used as an alternate to surgery. The purpose of this study is to investigate whether total hip arthroplasty followed by standard care is superior to progressive resistance training for improving hip function and pain in patients with end-stage hip osteoarthritis. The hypothesis is that patients treated with total hip arthroplasty will improve more than patients treated with progressive resistance training.

Turkish Validation of the HOOS-12

The Hip Disability and Osteoarthritis Outcome Score-12 (HOOS-12) is a short patient-reported outcome measure developed to assess pain, function, and hip-related quality of life in individuals with hip osteoarthritis. Although widely used internationally, a validated Turkish version is currently unavailable. This study aims to translate and culturally adapt the HOOS-12 into Turkish and evaluate its psychometric properties, including internal consistency, test-retest reliability, construct validity, structural validity, responsiveness, and measurement error, in Turkish-speaking patients with hip osteoarthritis.

Feasibility of the Hip Instructional Prehabilitation Program for Enhanced Recovery (HIPPER)

Osteoarthritis (OA), leading to hip replacement, is a leading contributor to global mobility impairment. Given the boom in the older demographic it is not surprising that there is an 11% increased demand for replacement every 5 years in Canada. Health promotion interventions, such as prehabilitation, defined as pre-surgical education, are vital to optimizing surgical outcomes, reducing hospitalization costs, accelerating rehabilitation, and reducing patient discomfort and pre-operative anxiety. HIPPER is a 2-year randomized controlled trial (RCT) that will assess feasibility indicators and clinical outcomes of online prehab education modules compared to online educational webinars. The feasibility indicators (process, resource, management, and treatment issues) and clinical outcomes (physical function, anxiety, depression, pain, daily activities, self-efficacy, and health related quality of life) will be assessed among Vancouver-dwelling older adults aged \> 50 years, with advanced hip osteoarthritis. The findings will lead to the refinement of the design protocol in order to evaluate a contemporary, standardized, and geographically accessible prehab education program in a large multi-site RCT.

The Ace Avanteon Study - A Randomized Controled Trial

The goal of this randomized controled trial is to compare if using of ancillary screws yields equal results as no use of ancillary screws in the ACE acetabulum cup of a total hip arthroplasty. Further, the migration of the Avanteon stem over time will be assessed. Patients included are patients with hip osteoarthritis from 65-80 years old. The purpose of this study is to compare implant migration and early fixation of a hybrid hip replacement combining the uncemented ACE acetabular component and the cemented Avanteon femoral stem, by using CT based Radiostereometric Analysis, a new innovative method for evaluating implant migration. Our study may predict the long term survival of the implants used. Participants will go through total hip arthroplasty, and be followed by CT-RSA, plain x-rays and patients reported outcome measures.

H1 Hip Resurfacing Arthroplasty

This is a prospective, non-randomized, consecutive series, multicentre, observational study to evaluate the clinical outcome of ceramic-on- ceramic hip resurfacing arthroplasty using the ceramic, non-porous, non-cemented H1 Hip Resurfacing Arthroplasty. It includes a safety study followed by an efficacy study. Patients will be followed up for 10-years postoperatively. The primary aim is to confirm the safety of the H1 hip resurfacing prosthesis by demonstrating non-inferiority of the H1 device in terms of survivorship. The secondary is to evaluate superiority of the ceramic-on-ceramic H1 hip resurfacing prosthesis compared to Metal-on-Metal (MoM) hip resurfacing in terms of absence of metal ion release.The primary end point is revision for any reason.

Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial

This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada.

Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator

Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period. However, the extent to which intravenous dexmedetomidine influences perioperative inflammatory biomarkers and clinical recovery in patients undergoing total hip arthroplasty under regional anesthesia remains unclear. This prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the effects of two doses of intravenous dexmedetomidine administered during spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, and quality of recovery following elective primary total hip arthroplasty.

Virtual Reality for Intraoperative Anxiolysis and Postoperative Agitation in Elderely Hip Arthroplasty Patients

This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under regional anesthesia. Half of the patients will experience an immersive, calming nature-based VR environment during the surgery, while the control group will receive standard care.

Prospective Catalystem CT-RSA

Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.