Using AttraX Putty to reduce pain in knee osteotomy
A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy
This study is testing if using AttraX Putty during knee surgery can help reduce pain after the operation for people with knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht, Utrecht) |
| Trial ID | NCT05992038 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of AttraX® Putty as a gap filler in open-wedge osteotomies for patients with unicompartmental knee osteoarthritis. The study aims to determine if filling the osteotomy gap with this synthetic ceramic reduces early postoperative pain compared to conventional osteotomy without the filler. Secondary objectives include assessing rehabilitation speed, local blood loss, bone union, surgical accuracy, and adverse events. The trial is single-blinded and involves a randomized controlled design.
Who should consider this trial
Good fit: Ideal candidates are individuals indicated for open-wedge osteotomy due to unicompartmental osteoarthritis of the knee.
Not a fit: Patients requiring osteotomy for cartilage treatment or other knee surgeries, or those with significant corrections above 10 mm, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery for patients undergoing knee osteotomy.
How similar studies have performed: Previous studies have shown promising results with similar synthetic bone fillers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * indication for an open-wedge osteotomy of the femur, tibia or double level due to unicompartmental osteoarthritis (OA). * Comply with all aspects of the treatment, including CT scans, radiographs and 1-year follow-up * Informed consent Exclusion Criteria: * Osteotomy for indication of cartilage treatment or other knee surgeries than unicompartmental OA * Correction using an open wedge above 10 mm * Pregnant women at time of enrollment or women who are planning to become pregnant during the duration of the study
Where this trial is running
Utrecht, Utrecht
- University medical center Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: R.J.H. Custers, Dr — UMC Utrecht
- Study coordinator: R.J.H. Custers, Dr
- Email: r.j.h.custers@umcutrecht.nl
- Phone: 088 7558327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.