Bone Infection (Osteomyelitis)

This research aims to compare how well two diagnostic methods—percutaneous aspiration and open biopsy—detect 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 1/2, 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 treatment's 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.

Researchers are evaluating the use of genex with gentamicin (genex G), an antibiotic-loaded bone void filler, to treat osteomyelitis in the extremities. This pivotal, multi-center, single-arm study includes patients with osteomyelitis classified from grades I to IV according to the Cierny-Mader system. The goal is to determine if genex G is a safe and effective part of surgical treatment for this condition, with participants followed for up to 24 months. All participants will undergo surgical debridement and receive genex G implanted during surgery to fill bone voids and support healing. They will also receive systemic antibiotics as clinically indicated by their treatment site. This study does not include a control group but compares results historically. The follow-up period extends to 24 months after surgery to monitor outcomes and safety. Participants will be assessed regularly throughout the study for infection recurrence, need for additional antibiotics or surgeries, bone healing, and any adverse events. Radiographic imaging and clinical examinations will evaluate bone formation and infection resolution. Quality of life will also be measured using the EQ-5D-5L questionnaire. The study aims to capture safety and effectiveness data over two years following treatment with genex G.

Total hip replacement is a common and effective surgery to improve quality of life, but infections around the artificial joint can be a serious problem. This trial studies whether using antibiotic-treated bone grafts can lower infection rates after hip replacement surgery compared to bone grafts treated with a placebo. It focuses on patients undergoing elective hip arthroplasty, including complex revision surgeries, aiming to reduce infections that often require additional operations. Participants are randomly assigned to one of two groups: one receives a combination of vancomycin and tobramycin antibiotics mixed into bone graft material, while the other group receives a placebo saline solution mixed with the bone graft. These treatments are applied locally during revision hip surgeries. This is a double-blind trial, meaning neither patients nor doctors know which treatment is given. The study follows participants for at least two years after surgery to assess outcomes. Throughout the trial, researchers will monitor participants for reoperations caused by infections sensitive to the antibiotics used. They will also track reasons and timing of any reoperation or implant revision within two and five years. Participants will undergo regular follow-up visits to evaluate infection status and joint function. The study collects data on bacterial types and antibiotic resistance in any infections. This close monitoring helps assess the safety and effectiveness of the antibiotic bone graft over time.

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 evaluating the use of shotgun metagenomics to diagnose chronic Prosthetic Joint Infection (PJI) compared to the adapted Musculoskeletal Infection Society (MSIS) diagnostic score and culture methods. PJI is a serious complication after joint replacement surgery that can lead to disability and increased health risks. The study aims to improve diagnosis by identifying the bacteria causing infection and their antibiotic resistance, helping guide better treatment decisions. This observational study involves collecting six intraoperative samples from each of 143 patients suspected of chronic PJI during surgery. In addition to routine tests, an extra blood sample will be taken for C-reactive protein (CRP) measurement. Shotgun metagenomics sequencing will be performed after all patient inclusions are complete, approximately one year after the study starts, to assess its diagnostic performance alongside standard culture methods. Participants will undergo preoperative check-ups and surgery with sample collection for microbiological analyses. Researchers will monitor bacterial presence, antibiotic resistance, and diagnostic accuracy using several outcome measures. The study will also examine the impact of prior antibiotic treatments on diagnosis. The total involvement duration includes the surgical period and one year of follow-up for metagenomics analysis and data review.

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.