Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 107 trials
NCT07569848
On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation. Recently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible. The customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process. The aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.
NCT07534189
This study evaluates the effects of a 3-week thermal spa treatment on knee joint movement in patients with knee osteoarthritis. Knee movement fluidity and gait parameters will be analyzed during standardized tasks using wearable inertial sensors (Xsens). Secondary outcomes include changes in pain, physical function, physical activity, quality of life, and blood transcriptomic profiles. Assessments will be performed at baseline, after treatment, and at 3- and 12-month follow-up visits.
NCT05487053
Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients. Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling. Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle. The possibility of enhanced recovery after total knee replacement is the reason to compare single-shot adductor canal block and continuous femoral nerve block.
NCT07464977
Reverse total shoulder arthroplasty (RTSA) is a well-established method to treat patients with irreparable rotator cuff tears and glenohumeral osteoarthritis. The biomechanical principle implies a medialization and distalization of the center of rotation (COR). Deficiencies in internal and external rotation constitute frequently encountered functional problems. Some studies showed reduced activation of the posterior deltoid in EMG measurements, which may explain the inability to compensate these movements. Lateralized prosthetic designs demonstrated increased external rotation through an alteration of the deltoid's lever arm. The aim of the study is to investigate the impact of lateralization on functional outcome and deltoid EMG activity in comparison to a standard implantation technique.
NCT07442812
This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol. The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV). Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.
NCT07414654
1. Study identification Study title: PSEUDO-CLAV - Single-center retrospective descriptive study of clavicle nonunion (pseudarthrosis): epidemiology, surgical management, and functional outcomes PSEUDO-clav\_Notice non oppositi… Study type: Observational study (retrospective, single-center) using existing medical records and imaging Study sponsor / data controller: CHU de Brest Scientific lead (principal investigator): Dr Agathe YVINOU (Orthopaedic \& Trauma Surgery, CHU de Brest) Data Protection Officer (DPO) contact: [email protected] 2. Why is this study being done? A clavicle nonunion (pseudarthrosis) is when a broken collarbone does not heal as expected and may cause pain, reduced shoulder function, and lower quality of life. Surgery is often used, but because this condition is uncommon, the investigators want to better understand: who is affected, which surgical strategies are used, how often the bone heals after surgery, what functional recovery and complications look like in real-life practice. 3. Goal of the study (use/keep this "fill-in" format) The goal of this observational study is to describe clavicle nonunion cases treated surgically at CHU de Brest and to estimate how often the clavicle heals after surgery, using information already collected during routine care. The main questions it aims to answer are: How often does the clavicle heal ("consolidate") after surgery? Main measure: union rate at \~6 months after surgery (assessment window approximately 4-8 months). PSEUDO-clav\_Protocole\_scientifi… How do patients recover in terms of function and symptoms, and what complications occur? Examples: shoulder function scores (Constant and/or DASH), pain, return to work/sport, complications and re-operations. PSEUDO-clav\_Protocole\_scientifi… If there is a comparison group (optional wording): Researchers may compare different surgical strategies (for example, plate fixation alone vs. plate fixation plus bone graft, and other techniques when used) to explore whether results differ for healing, recovery, or complications. PSEUDO-clav\_Protocole\_scientifi… 4. Who may be included? (participant population) This study may include adults who: were treated at CHU de Brest, and had surgery for clavicle nonunion between January 1, 2000 and December 31, 2024, and were 18 years or older at the time of the nonunion surgery, and have enough information in the medical record/imaging to evaluate outcomes. PSEUDO-clav\_Protocole\_scientifi… Estimated number of participants: up to about 30 cases in this center (because the condition is rare). PSEUDO-clav\_Protocole\_scientifi… 5. What will participants have to do? Nothing extra. This study: uses existing information already in the medical record and imaging systems, involves no additional visits, no extra tests, and no change to treatment, and does not require direct contact with patients. 6. What information will be used? Information may include (examples): medical history related to the injury and health conditions, details of the surgery (type of fixation, whether a bone graft was used), lab results (including microbiology if relevant), radiology/imaging reports and images, follow-up notes about pain, function, healing, complications, and re-operations. 7. Risks and benefits Risks to for the patients : Since no new procedures are done, the main risk is related to privacy/confidentiality of data. The study team puts protections in place to reduce this risk (see below). Benefits: the patients should not expect a direct personal benefit, because care is not changed. Results may help improve understanding of clavicle nonunion surgery, follow-up practices, and future care decisions. 8. How will privacy be protected? Data used for analysis will be pseudonymized (coded). Name and first name are not included in the research dataset. Only authorized members of the research team can access the data, using secure access (e.g., password-protected files and restricted hospital systems). Study results will be presented as grouped data, so individuals cannot be identified in publications or conference presentations. Data retention: research data are kept and archived for a limited duration (e.g., up to 5 years after the end of the study, per the study documentation). 9. Voluntary nature and patient's rights Because this is a retrospective study using existing records, participation is based on non-opposition (opt-out). The patient can: object to the use of data for this study, and request access, correction, or limitation of processing as permitted by data protection rules. How to object (opt out) of PSEUDO-CLAV: Email the DPO: [email protected], or use the CHU Brest transparency portal (as listed in the notice), or contact the study scientific lead, or write to CHU Brest (address listed in the notice). Choosing not to participate will not affect patient's medical care now or in the future
NCT05583864
The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.
NCT07364812
The Effect of Showing Intraoperative Cartilage Damage and Post-Implantation Range of Motion Photos to Patients on Early Clinical and Functional Outcomes in Patients Undergoing Total Knee Arthroplasty Objective: The aim of this study is to determine the early clinical and functional effects of showing photos of intraoperative cartilage damage and range of motion after prosthetic implantation to patients who undergo Total Knee Arthroplasty as part of the treatment for advanced gonarthrosis (stage 3-4). Patients and Methods: The study was initiated at Bezmialem Vakıf University with approval from the Ethics Committee (Approval Number: E.167479) on 03.10.2024. With a 95% confidence level and 80% power (average difference of 4 units, standard deviation of 6.3), at least 40 patients per group (2 groups) are required. Data will be analyzed using IBM SPSS Statistics 22.0 software. The t-test will be used to compare the mean differences of continuous variables between groups, the Chi-square test will be used for the distribution of categorical variables between groups, and Pearson correlation coefficient will be used to analyze the relationship between continuous variables. Descriptive statistics will include mean, standard deviation, correlation coefficient (r), frequency, and percentage values. A p-value of \<0.05 will be considered statistically significant. Exclusion criteria for our study include revision total knee arthroplasty surgeries, total knee arthroplasty surgeries following high tibial osteotomy, total knee arthroplasty surgeries after unicompartmental knee arthroplasty, and surgeries with advanced deformities requiring the use of revision implants.
NCT06920186
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
NCT07002086
This study was planned to investigate the physiopathology of bradycardia and hypotension that occur in some patients with total knee arthroplasty (TKA) between the ages of 65 and 90 years when the tourniquet, which is routinely used in patients with total knee arthroplasty (TKA), is opened at the end of the operation and to determine the physiopathology of these effects of the tourniquet and how these effects can be prevented.
NCT07032805
The objective of this clinical trial is to assess the effectiveness of a telemedicine approach in improving treatment adherence and functional outcomes in patients who have recently undergone total knee arthroplasty for primary osteoarthritis. The study focuses on patients aged between 50 and 75 years, with a BMI less than 35, and without known oncological or neurological diseases. Participants will receive personalized rehabilitation treatment, including posturographic assessment, psychomotivational framing, and telemedicine-based rehabilitation interventions. The aim is to provide a framework for adopting more detailed and personalized rehabilitative strategies. The main research questions are: • Primary: Reduction of pain (VAS), physical function (WOMAC, KOOS). • Secondary: Activities of daily living (Barthel Index, mRS); psycho-behavioral assessments (CEQ, PAM13, CG-PAM, COP-NIV); attitude toward technology (TAM); use of analgesics and walking aids. Sample size is estimated at 40 patients (20 per group), accounting for a 20% dropout rate, divided into: • Control Group: Standard outpatient rehabilitative treatment with a personalized exercise program. • Study Group: Standard outpatient rehabilitative treatment with a personalized exercise program plus telemonitoring via video calls. Procedures: • Recruitment and signing of informed consent; • Initial assessment (demographics, baseline tests, and posturography) and initiation of post-acute rehabilitation during hospitalization at T0; • Outpatient rehabilitative interventions with/without tele-rehabilitation support (twice weekly) at discharge, with follow-up assessments at T1 (1.5 months) and T2 (3 months); • Weekly recording of analgesic consumption via a dedicated diary; • Recording the date of discontinuation of walking aids.
NCT05547984
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
NCT05435690
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
NCT04580225
This randomized clinical trial (RCT) aims to compare clinical and radiographic outcomes of different partial wrist fusion techniques in participants with post-traumatic wrist arthritis. Participants with stage II or III scapholunate advanced collapse (SLAC) or scaphoid nonunion advanced collapse (SNAC) who meet the eligibility criteria will be randomly assigned to one of two parallel groups: Group A (partial wrist arthrodesis without triquetral excision i.e. four-corner arthrodesis), or Group B (partial wrist arthrodesis with triquetral excision i.e. three-corner or capitolunate arthrodesis with triquetral excision). The results of this study will provide evidence to guide surgeons in determining the ideal wrist fusion technique in the management of patients with post-traumatic wrist arthritis requiring surgery.
NCT06655558
The aging population is steadily increasing, partly due to increasing life expectancy. At the same time, chronic diseases, including those affecting the musculoskeletal system (e.g., osteoarthritis), whose prevalence increases with age, limit the daily activities of those affected and thus affect more and more people. Arthrosis is the most common form of these diseases worldwide. According to the l'Institut de la statistique du Québec, nearly one in two Quebecers aged 15 and over is affected by a chronic health problem. Knee orthosis is one form of treatment that helps patients suffering from knee gonarthrosis. This treatment aims to compensate for certain biomechanical deficits in patients. A variety of joint configurations exists to target specific biomechanical deficits. A constant challenge for companies manufacturing orthoses is transmitting the orthosis's biomechanical effect to the patient. The desired effect requires a change in the forces applied inside the knee, but the orthosis cannot directly transmit forces to the patient's bones due to its external nature to the body. Customization of orthoses is crucial to improve the transmission of the biomechanical effect as well as tolerance to it. O3D Inc. aims to validate the effectiveness of its new custom orthosis for treating knee gonarthrosis symptoms. Participants answered a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire before receiving their custom knee brace(Baseline) and after 8 weeks (56 days) of treatment.
NCT01409954
The purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. Patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. By using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. This will help reduce the need for revision surgeries and improve patient recovery.
NCT03372278
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
NCT04997005
This is a Post-Market Surveillance study of AMIStem-P femoral stem prosthesis
NCT06858800
To date, there is no gold standard for the treatment of severe trapeziometacarpal joint osteoarthritis. Despite the fact that new procedures have been described, techniques such hematoma distraction or ligament reconstruction tendon interposition are still valid non-implant options. The main hypothesis was that patients treated with LTRI technique would show superior clinical outcomes at one-year follow-up in terms of tip and key pinch and DASH scores in comparison with HDA technique. As secondary objectives, complication rates and surgical times were recorded.
NCT04317872
This randomized, single surgeon, placebo controlled, double blind study will be conducted in order to investigate whether or not peri-operative high doses of intravenous glucocorticoids improve short-term functional outcome after direct anterior total hip arthroplasty. So far, it has been proven that high dose glucocorticoids reduce immediate post-operative pain and nausea, but no data exists on functional outcome during the first 6 weeks. Our hypothesis is that patients in the intervention group will follow a so-called "get ahead, stay ahead" principle and that glucocorticoids can be considered an important tool (adjuvant treatment) in the enhanced recovery pathway after THA with significant socio-economic implications.