Bone Infection (Osteomyelitis)

This research aims to compare how well two diagnostic methodspercutaneous aspiration and open biopsydetect infections in shoulder and elbow joint replacements that need revision surgery. Periprosthetic joint infection PJI is a serious problem leading to many revision surgeries, and early, accurate diagnosis is crucial but challenging. The study focuses on improving diagnosis methods specifically for shoulder and elbow PJI, as current evidence mainly comes from hip and knee replacements. The study observes patients undergoing revision surgery after shoulder or elbow arthroplasty. It compares the accuracy of pre-operative joint aspiration, which collects fluid samples, against open biopsy, which obtains tissue samples during surgery. Both microbiological and histological tests will be used to assess infection presence. The study follows participants for up to 36 months to evaluate the diagnostic accuracy of these methods. Participants will undergo standard clinical assessments, including laboratory tests of blood and joint fluid, microbiological cultures, tissue analysis, and imaging. Researchers will track infection detection and compare results from aspiration and biopsy samples. The main outcome is the diagnostic accuracy over 36 months, with additional culture analysis completed within 14 days. The study does not involve experimental treatments but focuses on improving infection detection before surgery.

Researchers are studying participants with early or acute hematogenous periprosthetic joint infection PJI following total knee arthroplasty TKA or other joint replacement surgeries. The study aims to evaluate the safety, tolerability, and pharmacokinetics PK of TNP-2092 given by intra-articular IA injection alongside vancomycin intravenous IV and oral antibiotics. This Phase 12, randomized, controlled, open-label study explores treatment options for PJI patients requiring or not requiring debridement, antibiotics, and implant retention DAIR therapy or long-term antibiotic suppression. Participants are assigned to one of four groups a sentinel group receiving TNP-2092 IA plus vancomycin IV and oral antibiotics, an experimental group receiving the same, a control group receiving vancomycin IA plus vancomycin IV and oral antibiotics, or an expansion group receiving TNP-2092 IA based on background treatment. TNP-2092 is administered at 50 mg via IA injection once daily for 14 days, with dose adjustments allowed based on drug concentrations and safety. Oral antibiotic treatment lasts 8 weeks, and vancomycin IV and IA are given daily for 14 days. Participants undergo screening assessments within 7 days before starting the study and must agree to hospitalization for 2 weeks of IA injections. Researchers will monitor safety by tracking adverse events through Day 187 and measure TNP-2092 concentrations in synovial fluid and plasma at multiple time points. They will also assess treatment responses at Day 14 and study end, along with treatment failure within 6 months. The study involves regular blood tests and clinical evaluations to evaluate the treatments pharmacokinetics and local and systemic effects.

This trial focuses on patients with stage IV pressure ulcers complicated by osteomyelitis. It aims to evaluate the safety, tolerability, and the difference in effects between a new treatment called STIMULAN VG combined with debridement and systemic antibiotics, versus the standard care involving debridement and systemic antibiotics alone. The study is a phase II, open-label, randomized, multi-center trial designed to compare these approaches in treating this condition. Participants are randomly assigned to one of two groups one receives ulcer bursectomy, debridement, insertion of STIMULAN VG into the ulcer cavity, followed by flap or primary closure and peri-operative antibiotics the other group receives the standard care consisting of ulcer bursectomy, debridement, flap or primary closure, and peri-operative antibiotics without STIMULAN VG. The trial evaluates treatment over an 8-week period post-operation. During the study, participants will undergo assessments to determine individual patient success and clinical outcomes at the 8-week follow-up visit. Researchers will monitor safety and tolerability throughout the trial, with evaluations including imaging to confirm osteomyelitis and clinical status related to wound healing. Participants are expected to comply with scheduled visits, treatment plans, and study procedures for the duration of the trial.

Researchers are evaluating the effect of adding hyperbaric oxygen therapy after lower extremity amputation. The study focuses on patients who have had amputations due to chronic wounds, osteomyelitis, ischemia, or necrosis, conditions commonly associated with poor healing. Hyperbaric oxygen therapy has been used for decades to help heal difficult wounds by increasing oxygen levels in tissues, potentially improving healing at the amputation site and reducing the need for further amputations. Participants who have undergone lower extremity amputation will be randomly assigned to one of two groups. One group will receive 30 sessions of hyperbaric oxygen therapy, each lasting 90 minutes at 2.4 atmosphere absolute ATA with 100% oxygen. The first treatment must begin within seven days after amputation, and the therapy is provided as outpatient care after hospital discharge. The other group will receive standard care and outpatient follow-up without hyperbaric oxygen therapy. During the study, participants will be monitored for skin healing at the amputation site up to 12 months, including assessments at 12 weeks, 6 months, 9 months, and 1 year. Researchers will measure outcomes like intact skin without abnormal openings, time to wound closure, reamputations, wound revisions, hospital days, pain levels, quality of life, mobility, and foot and ankle function. Follow-up visits and evaluations will occur regularly to track healing progress and overall health after treatment.

Researchers are studying men with metastatic castration-sensitive prostate cancer to see if taking oral acetate can increase the amount of a gut bacterium called Akkermansia muciniphila. The trial aims to confirm this increase compared to standard care and to assess how well patients tolerate oral acetate. The study also explores whether higher levels of this bacterium relate to better metabolic health and bone strength. This is an early phase 1 clinical trial sponsored by Western University. Participants are randomly assigned to one of two groups. One group takes an apple cider vinegar caplet daily, containing 143 mg with 36% acetic acid, for three months. The other group receives standard care without supplementation. The study includes follow-up periods lasting up to six months to monitor changes and side effects. Throughout the study, stool samples will be collected at multiple time points to measure Akkermansia muciniphila levels. Researchers will also evaluate various metabolic markers such as blood sugar, cholesterol, and insulin resistance, plus bone health indicators. Side effects and tolerability will be checked after three months. Participants are monitored over six months to assess both primary and secondary outcomes related to metabolism and bone health.

This trial investigates the use of genex with gentamicin genex G, an antibiotic-loaded bone void filler, as part of the surgical treatment for osteomyelitis in the extremities. It is a multi-center, single-arm pivotal device study focusing on patients diagnosed with osteomyelitis classified by the Cierny-Mader system grades I-IV. The goal is to evaluate the safety and effectiveness of genex G in supporting bone healing and treating the infection. Participants will undergo surgical debridement followed by implantation of genex with gentamicin into the bone void as part of their treatment. They will also receive antibiotics according to clinical needs determined by their treatment site. The study involves a single treatment group where all participants receive genex G during surgery, and they will be monitored for 24 months after treatment to assess outcomes. During the study, participants will have regular follow-up visits to monitor infection resolution, bone healing, and any adverse events. Assessments include clinical evaluations, radiographic imaging, and quality of life questionnaires over a 24-month period. Researchers will measure the need for additional antibiotics or surgery, recurrence of infection signs, bone healing progress, and safety related to the device. The total participation time extends up to 24 months after surgery.

Researchers are evaluating whether antibiotic impregnated bone graft AIBG can reduce the risk of infection after total hip replacement THR, a common surgery to restore quality of life. Periprosthetic joint infection PJI is a serious complication affecting a small percentage of patients after primary or revision THR. Because the number of these surgeries is expected to rise, new methods to prevent infections, especially in complex cases where antibiotic-loaded bone cement is insufficient, are urgently needed. The study compares two groups of patients undergoing elective THR with bone grafts one group receives a combination of vancomycin and tobramycin antibiotics mixed with allograft bone, while the other group receives a placebo bone graft treated with saline. The treatment is applied locally during revision surgery. This randomized, double-blind trial aims to determine if the antibiotic-treated graft reduces infections requiring reoperation within two years after surgery. Participants will be monitored for at least two years after their hip replacement. Researchers will track the time to reoperation due to infection with bacteria sensitive to the antibiotics used, as well as other infection-related measures. The study involves clinical follow-up to assess infections and implant revisions, with safety and effectiveness monitored throughout the trial period, which continues until 2031.

Orthognathic surgery involves procedures to correct jaw and facial bone deformities, aiming to improve speech, jaw and dental function, appearance, and sleep apnea symptoms. This study evaluates the use of antibiotics to prevent infections after these surgeries, focusing on whether a single dose before surgery is as effective as a 24-hour course including post-operative doses. The research is motivated by concerns over antibiotic resistance and aims to find the best balance between infection prevention and minimizing antibiotic use. Participants are randomly assigned to one of two groups. Group A receives a single pre-operative dose of 2g intravenous cefazolin. Group B receives the same pre-operative dose plus three additional doses every 8 hours over 24 hours after surgery. Both groups follow the same surgical procedures and post-operative care, including use of a chlorhexidine mouth rinse for two weeks. Follow-ups occur at 2, 4, and 6 weeks post-surgery to monitor for surgical site infections and other complications. During the study, researchers collect information on patient age, sex, smoking status, surgical details, and any medication side effects. Surgical site infections are classified according to CDC criteria and recorded along with treatment details. Safety and adverse events are monitored continuously, and participants may withdraw at any time. Data will be stored securely and analyzed to determine if post-operative antibiotic doses provide additional benefits over a single pre-operative dose. Total participation lasts about 6 weeks after surgery with scheduled follow-up visits.

Researchers are conducting the Avis-PHAGEinLYON Clinic study at a single site to observe patients referred to the Hospices Civils de Lyon for medical advice regarding phage therapy between 2015 and 2028. The goal is to count how many requests for phage therapy the clinic receives, focusing on patients with bone infections. This is a non-interventional study, meaning no treatments are assigned as part of the research. The study involves collecting information from up to 1500 patients who have been referred for phage therapy consideration during the specified period. There are no treatment interventions instead, the study documents the number and characteristics of phage therapy requests made to the clinic. This data collection covers both past and ongoing patient referrals. Participants will be included based on their referral history and will receive information about the study. The main measure is the number of phage therapy requests at the time of inclusion. There are no additional procedures, treatments, or follow-up visits required, and participants usual medical care continues as normal throughout the study.

Researchers are evaluating treatment options for children aged 1 to 18 years with acute, uncomplicated bone and joint infections BJIs in a multi-center trial across eight major pediatric hospitals in Australia and New Zealand. The study aims to determine if treating these infections entirely with oral antibiotics is not worse than the standard approach, which begins with 1 to 7 days of intravenous IV antibiotics followed by oral antibiotics. The goal is to see if children can fully recover without the need for IV treatment at 3 months after starting therapy. Children in the trial are randomly assigned to one of two groups. One group receives high-dose oral cefalexin four times daily for 1 to 7 days, followed by a standard dose of oral cefalexin three times daily to complete a total 3-week course. The other group receives standard treatment with IV cefazolin or IV flucloxacillin for 1 to 7 days, then oral cefalexin three times daily for 3 weeks. This comparison will help assess whether the oral-only treatment can effectively replace initial IV therapy. Throughout the study, children will be monitored for recovery status at 3 months, including assessment of full recovery, disease recurrence at 6 and 12 months, and any complications or treatment-related side effects. Researchers will also evaluate quality of life using various pediatric health scales, treatment adherence, and cost-effectiveness over 12 months. Medication use and adherence will be reviewed at 3 weeks to understand how well children follow the treatment plan.