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Use of a Putty as Gap Filler in Open-wedge Osteotomy

RecruitingNAAges 18 Years - anyAllUMC Utrecht
NCT05992038 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperative phase. This is probably due to a combination of bony cut (bone pain) and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to potentially reduce postoperative pain by reducing the bleeding from the bone gap. Objective: The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster accelerated rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable su

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📋 Eligibility rules (as published)
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
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What it tests

  • Osteotomy with putty
  • Conventional osteotomy
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Where

1 site
University medical center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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