Clinical Trials Logo
  1. Home
  2. Osteoarthritis, Hip
  3. NCT05169229

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. — ABOGRAFT  

Osteoarthritis, Hip Clinical Trial

Official title:
Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial

Clinical Trial Summary

Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities. The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent. Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05169229
Study type Interventional
Source University Hospital, Linkoeping
Contact Daphne Wezenberg, PhD
Phone 0046101030000
Email daphne.wezenberg@liu.se
Status Recruiting
Phase Phase 2/Phase 3
Start date April 1, 2022
Completion date December 2031
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05773261 - Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups N/A
Recruiting NCT05223777 - KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA) N/A
Recruiting NCT04731077 - Avenir Complete Post-Market Clinical Follow-Up Study N/A
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT06162195 - The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement N/A
Withdrawn NCT02743208 - Evaluation of a Short Femoral Stem in Total Hip Arthroplasty N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Active, not recruiting NCT02229279 - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures N/A
Active, not recruiting NCT02851992 - A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem N/A
Completed NCT01700933 - Dose-response: Exercise Therapy on Hip Osteoarthritis N/A
Completed NCT01618708 - A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip N/A
Completed NCT01214954 - Early Rehabilitation After Total Hip Replacement N/A
Active, not recruiting NCT00294424 - Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements N/A
Terminated NCT00588861 - Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement N/A
Withdrawn NCT05054595 - Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention N/A
Terminated NCT00973141 - A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain Phase 2
Recruiting NCT05014113 - H-28 DELTA ST-C and Minima Retrospective Study.
Completed NCT01066936 - Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Recruiting NCT06185036 - Histological Validation of dGEMRIC Indices as a Quantitative Biomarker for Cartilage Damage in the Hip Joint