Clinical Research Directory

Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain

The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use. Deliverables: \[1\] Adapt and refine open pilot protocol, patient recruitment, and other study materials. \[2\] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.

The Duration of Spinal Anaesthesia - a Prospective, Observational Cohort Study

Today, surgery in an ambulatory setting is preferred for many reasons. Total hip and knee arthroplasty (THA and TKA) are now procedures where patients can be sent home on the same day of the surgical procedure. However, this requires substantial knowledge of factors affecting the length of hospital stay. In this prospective, observational cohort study, we will investigate factors that affect the duration of spinal anaesthesia which is often used in THA and TKA. The aim is to gather enough data to be able to determine how local anaesthetic volume and dose affect the duration of spinal anaesthesia. This will enable us to decide whether spinal anaesthesia is a good option when performing TKA and THA in an ambulatory setting.

Pediatric Orthopaedic Implant Safety & Efficacy

Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy. Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).

Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

Metallosis on Tissues and Serum Metal Levels in Children

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.

CERAMENT™| Bone Void Filler Device Registry

A device registry to compile data on the performance of CERAMENT BONE VOID FILLER in normal use.

Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)

Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis. The improvement in knowledge of ankle joint biomechanics, instrumentation, surgical approach may led to even higher clinical results in comparison to arthrodesis. Many of the studies reporting the results of ankle replacement are provided by surgeons involved at least in the initial design of the implant. Thus, familiarity with the system can be a potential bias affecting outcomes and orthopedic surgeons may find difficulties in reproducing the results. In this study, we will assess the clinical and radiological outcomes in patients who underwent this procedure performed by non-designer surgeons

SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function

The primary objective of the study is to determine in adult patients with a rotator cuff tear, what size and pattern of rotator cuff tear would result in damage to the suprascapular nerve. The secondary objectives are 1. To determine if an injured suprascapular nerve can recover if the rotator cuff tear is surgically repaired. 2. To determine if there is a limit of retraction before the suprascapular nerve is irreversibly damaged. 3. To determine factors that are protective against SSN injury. 4. Can the patient data gathered be used to optimise operative procedures.

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.

A Study to Compare Early and Partial Weight-bearing After Hallux Valgus Surgery

This is a two-arm randomized controlled trial with the aim to evaluate the effectiveness and safety of post-operative management after a modified Lapidus arthrodesis with/without an Akin or a Weil/Hohmann surgery fusion with immediate complete weight-bearing compared with partial weight-bearing (10 - 15kg) for 6 weeks as a novel approach for rehabilitation after a foot surgery.

Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.

Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture

Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion. Evidence has shown that reverse total shoulder arthroplasty (rTSA) is an effective option to improve pain and function for patients with acute displaced proximal humerus fractures. Given that patients undergoing rTSA for proximal humerus fractures typically experience worse functional outcomes, worse patient-reported outcomes, and higher rates of complication compared to those with elective indications for surgical intervention, it is critical to determine a secure path to recovery for these patients after surgery. Early rehabilitation has been proposed to be safe and effective for patients who undergo rTSA for elective indications; however, there is a paucity of research evaluating safety and effectiveness of timing of rehabilitation for rTSA patients in the trauma setting. Currently, there exists a great variability in postoperative rehabilitation protocols across orthopaedic practices. This study's objective is to determine the safety and effectiveness of early postoperative rehabilitation on the outcomes and postoperative complications of patients undergoing rTSA for proximal humerus fractures in order to provide more specific recommendations for this patient population.

Effect of Pre-Surgery Constipation Podcast: A RCT

In this study, the investigators will evaluate the effect of a podcast on constipation on the number of patients with constipation. It is hypothesised that the podcast on constipation, will prevent constipation in the period leading up to and after surgery. This is a randomised controlled trial. The population of the study will consist of patients with planned orthopaedic surgery (knee, hip, shoulder, and back) at the Elective Surgery Centre, Silkeborg Regional Hospital. The sample of the study will consist of patients 18 years or older, who are able to understand, read and write Danish, has an email address, has access to and is able to navigate a computer, tablet or smartphone, does not have severe hearing loss, does not have cognitive dysfunction or other mental illness that would make participation difficult, is not participating in other trials at the Elective Surgery Centre, is not diagnosed with a gastrointestinal condition (Crohns, Colitis ulcerosa or celiac disease), and does not previously have received a colostomy or ileostomy. Patients will be randomised to either a control group or an intervention group. Both groups will receive the standard information at the preoperative consultation and after randomisation. The intervention group will also receive a podcast. The study will collect data using an online questionnaire, that includes The ROME IV Diagnostic Criteria for functional constipation and "The Patient Assessment of Constipation Quality of Life (PAC-QOL)". Data will be collected at 4 times: (1) after the preoperative consultation (baseline), (2) 1-2 days prior to surgery, (3) 1 week after surgery, and (4) 4 weeks after surgery.

A Clinical Registry of Orthobiologics Procedures

The purpose of the Registry study is to observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures for treatment of musculoskeletal disorders.

Study on the Preventive Effect of Establishing an Integrated Working Group of Doctors and Nurses in Operating Room

To explore the preventive effect and clinical enlightenment of establishing an integrated working group of doctors and nurses in operating room on incision infection in orthopedic surgery.

In'Oss™ (MBCP® Putty) Ortho

Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery

TENS for Relief of Postoperative Pain in Orthopedic Patients

To ensure early mobilization, minimize suffering, and to prevent postoperative complications postoperative pain should be reduced as soon and as effectively as possible. A non-pharmacological post-operative intervention in terms of the application of transcutaneous electrical nerve stimulation (TENS), could have the potential to accelerate early mobilization and reduce the use of opioids. The overall aim is to demonstrate that the addition of TENS to standard postoperative pain management of orthopedic patients can alleviate pain during mobilization and at rest as well as reduce opioid consumption.

Hybrid Approach to Pediatric Rehabilitation

Children and youth recovering from acquired injuries typically receive therapy via in-patient or outpatient rehabilitation (OPR). Families from peripheral areas often face significant time and financial burdens to access treatment. Over the past decade, evidence supporting the effectiveness of remote (online) rehabilitation has increased. Objectives: 1. Identify facilitators and barriers to hybrid service adoption. 2. Develop a hybrid telerehabilitation program for youth that is at least equivalent (non-inferior) to conventional, in-person therapy. 3. Compare hybrid rehabilitation to in-person rehabilitation at two centers in Israel in terms of: Adherence to therapy, Therapeutic alliance, Perceived quality of care (families and therapists), Functional effectiveness (measured by pre-post change in the Pediatric Evaluation of Disability Inventory, PEDI), Cost-effectiveness (including training requirements, physical space requirements, and costs); 4. Provide best practice recommendations for hybrid rehabilitation in children. Research Methods: Focus Groups: Experts will develop a two-month hybrid program for approximately 200 children in OPR, commencing one month after in-person rehabilitation. Evaluation Metrics: Therapy adherence, therapeutic alliance, and perceived quality of care will be assessed monthly and compared to in-person treatment. Insights will inform best practice guidelines for hybrid telerehabilitation. Data Collection: Thematic Analysis: Analyzing focus group information. Comparative Metrics: Comparing measures of adherence, therapeutic alliance, and perceived quality of care between hybrid and in-person programs. Difference-in-Difference Approach: Assessing functional differences between in-person and remote therapy. Cost Analysis: Estimating direct and indirect costs per child for in-person versus remote rehabilitation.

Improve the Quality of Care in Patients With Orthopaedic Disorders

The main objective of the investigators is to improve the quality of care in patients with orthopedic disorders followed in St Luc hospital (Brussels Belgium). To do this, the investigators want to assess the impact of Orthopedic treatments at the structural level (bone structure, muscle, etc.), at the functional level (mobility, strength, stiffness...), on the restriction of activities of patients (walking, make its care daily..) and on the limitation of participation in the life of every day (sport, work, social life, cultural...). This functional evaluation of patients with orthopedic disorders by the ICF model is an original approach rarely used in muscular-skeletal impairments that can very improve the management of these patients and their quality of life. In addition, the investigators associate the harvesting of all medical and computer data collected by high-precision tools in the surgical treatments, to better define the surgical precision and improve the quality of surgical care.

BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery

To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)

Pneumatic Artificial Muscles (PAMs), inspired by the structure and function of natural muscles, offer a lightweight and adaptable solution compared to traditional rigid Ankle Foot Orthosis(AFOs).

Risk for Reoperation After First MTP Joint Arthrodesis

We will screen all first metatarsophalangeal joint arthrodeses performed between 2010 and 2022 in Helsinki University Hospital. Information about demographics and additional diagnoses will be yielded from data pool of medical records. Additionally we review pre- and post-operative x-rays for first MTP joint angles and OR records for operative techniques. Our aim is to find associations between those known variables and risk for reoperation in two years after operation.

CAsting and REhabilitation Versus Supervised Neglect for Osteochondral Lesions of the Talus in the Pediatric Population

Rationale: OCLs (osteochondral lesions) of the talus can be congenital or can occur after trauma or in patients with juvenile idiopathic arthritis (JIA). The main complaint of an OCL is pain during weightbearing activities. Therefore, these lesions have significant impact on the health status of patients. Objective: The aim of this study is to optimize the treatment for skeletally immature patients with an osteochondral lesion. The hypothesis is that a period of immobilization and supervised rehabilitation will lead to better clinical and radiological outcomes compared with standard care which is a ''skill-full'' neglect. Study design: Observational comparative study Study population: Skeletally immature children with an osteochondral lesion of the talus diagnosed on CT. Intervention: Patients in the intervention group will undergo an 8-week period of casting and walking on crutches. Afterwards, they will receive a protocolled period of rehabilitation under supervision of a physical therapist. The control group will have the standard care as treatment. Main study parameters/endpoints: the main study outcome is the difference between the two groups on the OxAFQ-C. Secondary study outcomes are radiologic changes in terms of morphology and lesion size, NRS during weight bearing and quality of life measured with a Peds-QL, EQ-5D-y and AAS. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden that patients will have is mainly the time that they have to spent on fulfilling the questionnaires.

Analyzing Orthopedic Patient Experience Patterns in Medical Trials

Clinical study enrollment has historically been heavily biased toward specific demographics. Several people will be invited to participate in this study so that it may collect a variety of data about orthopedic clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with orthopedic disorders who are invited to take part in medical research will benefit from the analysis of the data.