Using AttraX Putty to reduce pain in knee osteotomy
Official title: A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy
Run by UMC Utrecht · NCT05992038 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht, Utrecht) |
| Status | Recruiting |
| Started | September 20, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | April 29, 2026 |
| Trial ID | NCT05992038 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals indicated for open-wedge osteotomy due to unicompartmental osteoarthritis of the knee.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar synthetic bone fillers, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.