Clinical Research Directory

MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)

This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.

Comparison of the Direct Anterior Approach (DAA) and the Direct Lateral Approach (DLA) in Patients Treated With Partial Hip Replacement for Femoral Neck Fracture Based on Postoperative Functional Status

The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures. The main questions it aims to answer are: * Does the direct anterior approach (DAA) result in superior postoperative functional recovery compared with the direct lateral approach (DLA)? * Are mortality, complications, hospital utilization, and readmission rates different between the two surgical approaches? Researchers will compare hemiarthroplasty performed using the direct anterior approach to hemiarthroplasty performed using the direct lateral approach to determine whether surgical approach influences postoperative function, complications, and survival. Participants will: * Undergo hemiarthroplasty for displaced femoral neck fracture using a randomly assigned surgical approach (DAA or DLA) * Complete a baseline functional assessment using the Activities of Daily Living (ADL) questionnaire before surgery * Have perioperative data collected during hospitalization, including laboratory values, operative details, blood loss, transfusions, analgesic use, complications, length of stay, and in-hospital mortality * Attend follow-up clinic visits at 6 weeks and 3 months after surgery * Complete postoperative functional assessment using the Harris Hip Score at both follow-up visits * Have demographic data, complications, readmissions, and mortality monitored through review of electronic medical records

Observational Study to Evaluate Long-Term Outcome in Hip Hemiarthroplasty

This PMCF study is designed to collect safety and efficacy data on hip hemiarthroplasty surgeries with Corin BiPolar-i shell and the Oceane+ or Meije Duo femoral stem up to 10 years.

Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for Pericapsular Nerve Group Block in Hip Arthroplasty (PENG)

The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are: 1. Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction? 2. What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery? Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery. Participants will: 1. Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance. 2. Undergo hip replacement surgery under spinal anesthesia. 3. Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.

Evaluating a Strategy to Improve Pre-Anesthesia Care Discussions (My Anesthesia Choice-Hip Fracture)

The objective of this study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication, paired with brief clinician training. The evaluation will occur via a stepped wedge, cluster randomized trial to be carried out over a period of 34 months.

Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture

Rational for conducting the study: Periprosthetic joint infection (PJI) is the most feared complication following prosthetic replacement of the hip joint and is associated with increased mortality, morbidity and economic burden. The aim of the trial is to investigate whether the risk of periprosthetic joint infection after treatment with hemiarthroplasty performed due to femoral neck fracture is reduced after the use of dual-impregnated antibiotic loaded cement. The primary outcome variable is the incidence of periprosthetic joint infection within one year after the index procedure. Secondary outcome variables include the occurrence of re-operations for any reason, bacteriology, antibiotic treatment, mortality and health care costs.

This is a Study to Verify if Periarticular Hip Injection of Corticosteroid After Hip Replacement Reduce the Pain and the Hospitalisation Time

The investigators are going to evaluate if periarticular corticosteroid injection during endoprothesis implantation can lead to any advantage to the patients, namely if it can reduce post-operative pain, lenght and cost of hospitalisation, use of analgesics drugs.

Sacral ESPB vs. PENG Block for Hip Hemiarthroplasty Analgesia

Sacral erector spinae plane block(S-ESPB) has been recently described. Case reports are showing that it is useful in various types of surgery. In case presentations, it has been reported as effective in providing analgesia in the posterior branches of the sacral nerves in pilonidal sinus surgery, in the treatment of radicular pain at the L5 - S1 level, after a sex reassignment operation and hypospadias surgery, and its use in combination with lumbar ESPB for analgesia was reported after hip prosthesis surgery . Described in 2018, pericapsular nerve group (PENG) block selectively targets the articular branches of the femoral and accessory obturator nerves thereby providing potential motorsparing analgesia for hip surgery . Recent studies found that PENG block targets the articular branches of the femoral and accessory obturator nerves, only anesthetizes the anterior hip joint sparing posterior part , as well as there was a motor impairment after block which is from local anesthetic (LA) diffusion to the femoral nerve . Motor-sparing regional anesthesia techniques have emerged as a safer alternative, balancing effective pain relief with the preservation of quadriceps function . These techniques align with Enhanced Recovery After Surgery (ERAS) protocols, which emphasize multimodal pain control, opioid minimization, and early mobility to reduce complications such as venous thromboembolism (VTE) and postoperative pneumonia .

Minimally Displaced Femoral Neck Fracture Pilot Study

The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy minimally displaced femoral neck fracture (FNF) treated with surgery will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, hip arthroplasty or internal fixation. Participants will be followed for 1 year.

Evaluation of Fracture Migration After Internal Fixation of Femoral Neck Fractures in Younger Adults: A Clinical RCT Using RSA

The goal of the clinical trial is to compare different surgical methods for internal fixation of femoral neck fractures in younger adults. The main question it aims to answer is: Is internal fixation with the novel implant consisting of three angle stable screws locked together by a plate equal to internal fixation with cancellous screws or a sliding hip screw in younger adults under 65 years of age in terms of fracture migration? The study will examine how stable the fracture remains during healing. This will be measured by assessing how much the fracture moves after surgery using a highly precise imaging method called radiostereometric analysis (RSA). The study will also record complications and evaluate pain, health related quality of life, and hip function over time. The participants will be treated with either a novel angle stable implant (Dynaloc), cannulated cancellous screws or sliding hip screw and followed up at 6 weeks, 12 weeks, 6 months and 12 months. Recruitment will continue until 75 participants, 25 in each group, have completed the 12-week follow-up for the primary outcome.

Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery

Femoral neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. This prospective observational study aims to compare the efficacy of lumbar and sacral plexus block with fascia iliaca block combined with low-dose spinal anesthesia in terms of severe intraoperative hypotension and postoperative analgesic outcomes in patients undergoing surgery for femoral neck fracture.

Population Pharmacokinetics and Pharmacodynamics of Ciprofol

The goal of this observational study is to learn how the anesthetic drug ciprofol works in older adults who are having limb surgery under general anesthesia at Shanghai Geriatric Medical Center. The study will help researchers build a population model to better understand how the drug moves through the body (PK) and how it affects patients (PD). This model may help doctors use a Target-Controlled Infusion (TCI) system to adjust the drug dose more precisely. The main question it aims to answer is: Does ciprofol work safely and effectively in older adults during orthopedic surgery? Participants already receiving ciprofol as part of their regular anesthesia care will: 1. Provide blood samples at different time points during and after surgery. 2. Have their vital signs and anesthesia-related data recorded before, during, and after surgery. 3. Be monitored for side effects and recovery indicators such as the Aldrete score and signs of postoperative delirium. Researchers will use this information to: 1. Build and test a population PK/PD model for ciprofol. 2. Simulate recommended TCI dosing plans. 3. Explore how individual responses to ciprofol relate to recovery and safety outcomes. This study may help improve anesthesia care for elder adults by making drug dosing safer and more effective.

Open vs Closed Reduction in Femoral Neck Fractures Using Anterolateral vs Direct Lateral Approach

Outcomes of open vs closed reduction if emoral neck fractures

Avenir® Cemented Hip Stem - PMCF

The objective of this post-market clinical follow-up study is to confirm the safety and performance of the Avenir® Cemented Hip stem when used in primary total hip arthroplasty.

Artificial Intelligence-Assisted vs Surgeon-Planned Trajectories in Freehand Femoral Neck Screw Fixation

The goal of this clinical trial is to compare two different methods of screw path planning-AI-assisted versus surgeon-directed-in freehand percutaneous femoral neck fracture fixation surgery. The study will include adult patients diagnosed with femoral neck fractures who are eligible for cannulated screw fixation under fluoroscopic guidance.The main questions it aims to answer are: Does AI-assisted screw path planning improve the radiographic accuracy of screw placement (screw deviation, tip position, and inter-screw parallelism)? Does AI-assisted planning reduce operative time, number of intraoperative fluoroscopy exposures, intraoperative blood loss (mL) and surgeon workload compared with surgeon-directed planning? Does AI-assisted planning reduce postoperative complications and improve functional outcomes compared to surgeon-directed planning? Researchers will compare the AI-assisted planning group to the surgeon-directed planning group to determine whether AI guidance contributes to enhanced surgical precision, reduced intraoperative burden, and improved recovery outcomes. Participants will: Undergo freehand percutaneous internal fixation of femoral neck fractures with either AI-assisted or surgeon-directed screw path planning, Receive standardized perioperative care and follow-up at defined intervals, Be evaluated through clinical assessments, imaging studies, and documentation of intraoperative and postoperative metrics over a 12-month follow-up period.

G7 Freedom Constrained Vivacit-E Liners

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures

The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are: * which peripheral nerve block is the best regarding analgesia * which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia? * which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous? * which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy? * what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery? * what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution. All respondents will, in addition to obligatory intraoperative monitoring,: * be thoroughly examined by anesthesiologists before surgery * be closely monitored after surgery, until their hospital discharge.

Hip Socket Erosion Study

The aim of this exploratory retrospective study is to gain a better understanding about the occurrence of acetabular erosion in patients after after hip hemiarthroplasty. The main objectives are i) to summarise a selection of basic patient characteristics of all patients of ≤ 75 years of age with a femoral neck fracture who have received either HA or THA, ii) to explore the proportion of patients after HA who developed acetabular erosion in the first years post-surgery and iii) to explore the proportion of patients after HA for whom acetabular erosion was the main reason for conversion surgery from HA to THA. A secondary objective is to assess the observer reliability of, and explore the association between, the Baker classification grading and Köhler line measurements. All participants approached for participation in the main phase of the study will be asked to give their written informed consent to use their patient data. Patients who are willing to participate will also be asked to complete a short paper survey to collect data that is not available from their health records.

G7 BiSpherical Acetabular Shell PMCF Study

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

Exception Cementless Hip Stem

This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. The objectives of this study are to confirm the long-term safety, performance and clinical benefits the Exception Cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

G7 Dual Mobility With Vivacit-E or Longevity PMCF

This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty

Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture

Investigators will compare the clinical outcomes of femoral neck system with conventional multiple cannulated screw in non-displaced femoral neck fracture.

Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.

Insignia™ Hip Stem Outcomes Study

The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.