Clinical Research Directory

Marrow Cellution™ vs. Traditional BMA Harvest Project

Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

Pericapsular Nerve Group (PENG) Block Combined With Lateral Femoral Cutaneous Nerve (LFCN) Block or Wound Infiltration for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Randomized Controlled Trial

This prospective, randomized controlled trial aims to compare two multimodal regional anesthesia strategies for postoperative analgesia in elective total hip arthroplasty (THA) performed via anterior approach. Patients will be randomized to receive either a Pericapsular Nerve Group (PENG) block combined with a Lateral Femoral Cutaneous Nerve (LFCN) block, or a PENG block combined with wound infiltration (WI). The primary outcome is postoperative pain intensity at rest, measured by Numerical Rating Scale (NRS) at 6 hours after surgery. Secondary outcomes include dynamic pain scores at 6, 24, and 48 hours, total opioid consumption, time to first rescue analgesia, quadriceps strength, hip flexion angle, length of stay, and adverse events. All procedures are routinely used in clinical practice and carry minimal additional risk. Safety will be continuously monitored by the Principal Investigator and the study team according to an internal Safety Monitoring Plan.

Knee-hip Surgery Wait-list Support Program

This project will outline a pre-surgery support program that identifies risk factors related to poor surgical outcomes and recommends actions to improve these before surgery. The main questions this study attempts to answer are: 1. Is a formalized knee-hip pre-surgery support program feasible, measured by recruitment rate, adherence, and completion rate? 2. Does the support program improve surgical risk factors including hemoglobin A1c (HB A1C), blood pressure, hemoglobin, estimated glomerular filtration rate (eGFR), frailty score, and physical fitness and function (measured with the 2-minute step test and 30s second sit to stand test)? Participants will participate in education, medical navigation, and exercise.

Radiographic Stability of Hip Prosthesis Prior to Revision Surgery

The goal of this validation study is to compare the preoperative implant stability, assessed by Implant Movement Analysis (IMA), provocation dual CT scans, with the intraoperative stability evaluation in revision hip arthoplasty. The main question it aims to answer is: Does IMA reflect the intraoperative clinical evaluation of implant stability? Participants scheduled for revision hip arthoplasty will undergo IMA preoperativelly in addition to rutine clinical work up. During revision arthoplasty, a surgeon blinded to the IMA results will assess clinically the stability of the hip prosthesis. IMA will be compared with the intraoperative findings to assess IMAs sensitivity and specificity

Optimized MRI of Patients With Hip Arthroplasty

This is a single-center single-arm clinical trial with a paired design which compares the effectiveness of 3T MRI with (modified) and without (standard) radiofrequency pulse polarization optimization in reducing metal-related artifacts in patients with hip arthroplasty implants.

Nexus Evaluation Primary Trident II Uncemented Shell

This is a prospective cohort study assessing the survival of a new acetabula component which is based on the original Trident acetabular system (cementless shell) which is used for Total Hip Arthroplasty. The manufacturer recently introduced the evolution of this product, the Trident® II acetabular shell which was launched in 2017. This implant is CE marked and is now widely available for the UK market, however has minimal clinical outcomes data to support its use. As part of a stepwise introduction of devices to orthopaedic practice. This study will report the 10 year implant survival and patient functional outcomes of this new implant.

PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty

The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery. The main questions it aims to answer are: Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery. Participants will: Be randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.

Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject

Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

Restoration Anatomic Acetabular Shell Revision Study

This study will be a non-randomized, ambidirectional (retrospective and prospective) study where all subjects will be followed prospectively. The study will evaluate the survivorship of the RAS acetabular component in a previously failed total hip arthroplasty (THA) in a consecutive series of subjects who meet the eligibility criteria.

Cryoneurolysis in Patients Awaiting Total Hip and Knee Arthroplasty

During the COVID-19 pandemic, there was a drastic increase in surgical wait times across Canada, notably for patients awaiting total knee and hip arthroplasty. Currently the average wait time for total hip arthroplasty (THA) in Alberta is 16 weeks with the 90th percentile of wait times being 47 weeks. The average wait for total knee arthroplasty (TKA) in Alberta is 20 weeks with the 90th percentile of wait times being 60 weeks. As the waitlist for these surgeries grows and with limited resources to increase the number of surgeries being performed, there is a critical need for strategies to manage the pain experienced by patients during these long waiting periods. Many patients awaiting surgery are placed onto long-term opioid therapy to manage their pain. There are, however, significant risks associated with the extended use of opioids for pain management, such as addiction, opioid abuse, increased risk of overdose, increased risk of fractures, and increased risk of adverse cardiac events. Recognizing these risks, different strategies need to be employed to attempt to minimize the opioid burden faced by those waiting for surgery. One potential strategy is to utilize regional anesthesia for analgesia rather than relying on opioids. Regional anesthesia with nerve blocks using local anesthetic has been used in the management of preoperative pain for patients awaiting surgery for hip fracture and has been shown to be effective in reducing pain, opioid use, and the risk of serious adverse effects. However, for patients with hip fractures, their surgery usually occurs within 36 hours due to significant risks which occur beyond that timeframe. For patients waiting for THA and TKA, the surgical wait time could be weeks to months. Providing daily nerve blocks or even weekly catheters for an individual waiting up to a year for surgery is not sustainable and carries significant risks with repeated injections. New regional anesthesia techniques lasting a longer period of time are needed. One promising intervention is to utilize cryoneurolysis. Cryoneurolysis involves treating targeted nerves using extremely low temperatures. This disrupts nerve conduction and pain impulses. Importantly, connective tissue components of the nerve are left intact allowing for regeneration over time. Because of this, cryoneurolysis is a well-established treatment for chronic and acute pain due to its effectiveness and low risk safety profile. While cryoneurolysis is well-established in its use treating chronic and surgical pain, one limitation is that it is focused primarily on postoperative pain. Our study intends to primarily evaluate the efficacy of cryoneurolysis as a preoperative pain management intervention. Establishing the use of cryoneurolysis for preoperative pain will provide a valuable resource for reducing the pain patients experience while awaiting surgery, leading to decreased opioid use and improved overall well-being. The investigators will be recruiting 30 participants total (15 having TKA and 15 having THA) that will be given cryoneurolysis while waiting for their surgery.

Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty

Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly, however, it is associated with moderate to severe postoperative pain. Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesia techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components of enhanced recovery after surgery (ERAS). Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA. Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA under general anesthesia

PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery

This randomized controlled trial (RCT) compares the analgesic effectiveness of two regional anesthesia techniques-Pericapsular Nerve Group (PENG) block combined with Lateral Femoral Cutaneous Nerve Block (LFCB) versus Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB and S-ESPB)-in pediatric patients undergoing hip surgery.

CoCrMo LOCK Bipolar Femoral Heads FU

Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CoCrMo LOCK bipolar femoral heads. The eligible study population is represented by the entire population that underwent a hip replacement with CoCrMo LOCK bipolar femoral heads from 1st January 2023 onwards at the site in accordance with the indication for use of the product.

Assessment of Safety and Performances of HYPE SCS Stem Associated to NOVAE Sunfit TH Acetabular Cup in Hip Arthroplasty

Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures. HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip. Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product. Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.

The Pericapsular Nerve Block in Total Hip Arthroplasty

In order to continue progressing towards outpatient total hip arthroplasty (THA), methods to adequately manage postoperative pain is of paramount importance. The purpose of this study is to quantify the effectiveness of the pericapsular nerve block in total hip arthroplasty in comparison to the fascia iliaca nerve block.

Polyethylene Wear Particle Analysis of THA

Purpose of research The purpose of this study was to demonstrate that polyethylene (Vitamin E-containing polyethylene), a newly introduced biomaterial for tibial inserts in hip replacement surgery and widely used clinically, but whose mid- to long-term clinical results are still unknown, is superior to conventional polyethylene in vivo. The aim of this project is to conduct an international multi-center joint research study to determine whether polyethylene wear debris production can be reduced in the future, using an in vivo polyethylene wear debris analysis method that the investigators developed as a method that can provide early feedback.

Sexual Counseling's Impact on Hip Replacement Patients' Sexual Function and Quality of Life: a PLISSIT Model Study

This study investigates the influence of sexual counseling using the PLISSIT model on various aspects of patients undergoing hip replacement. The PLISSIT model is employed to guide the counseling process. The research aims to assess how this counseling intervention affects sexual function, quality of life, and overall comfort for these patients. By addressing these factors, the study seeks to shed light on potential improvements in the well-being and experiences of individuals who have undergone hip replacement surgery.

Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology

Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.

Post Market Clinical Follow-up of Dual-mobility Acetabular Cup EUROSCUP MOBILE

EUROSCUP MOBILE is intended for use in primary and revision total hip replacement surgery. Hip replacement is intended to provide increased patient mobility and reduce pain by replacing the damages hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. As part of post market vigilance, EUROS will collect data on EUROSCUP MOBILE performances and safety

Pericapsular Nerve Block Versus Intrathecal Morphine for Analgesia After Primary Hip Arthroplasty

The aim of this clinical trial is to compare the analgesic effect of pericapsular nerve block (PENG) with intrathecal morphine in patients scheduled for total hip replacement surgery. The main question to be answered is whether the PENG block is equivalent to intrathecal morphine in reducing postoperative pain. Participants will be randomised into two groups. Patients assigned to the PENG group will receive spinal anaesthesia with local anaesthetic (isobaric bupivacaine) alone and a PENG block. Patients assigned to the intrathecal morphine (ITM) group will receive spinal anaesthesia with a mixture of local anaesthetic (isobaric bupivacaine) and morphine (100 mcg) and a sham PENG block to ensure patient blinding.

Hip Prospective Study

In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable. Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses. HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.

Prospective and Obsevational Study of Total Hip Prothesis: HYPE Stem

The purpose of this study is to validate the performance and the safety of the HYPE (SERF) prothesis in compliance with the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 guide ( guideline for post-market follow-up), which provides for the implementation of a systematic procedure for the follow-up of clinical data in order to verify the performance claimed for medical devices .

Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Hip Arthroplasty

Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for hip arthroplasty