A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The mean NRS pain score
研究概览
简要总结
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 surgical accuracy, and the occurrence of (serious) adverse events.
Study design: Single-blinded, prospective, randomized controlled trial.
Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy.
Intervention: According to a randomization scheme, the osteotomy gap will be filled with either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional method).
Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS) pain during the first week postoperative. The secondary study endpoints are faster rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and (serious) adverse events.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients may have the advantage of experiencing less pain postoperatively if they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation. Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone fusion and excessive bone growth. However, the preclinical studies and clinical studies show that the use of AttraX® Putty is safe for use in humans.
详细描述
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.
AttraX® Putty: AttraX® putty is a synthetic ceramic which consists of calcium phosphate granules and hydroxyapatite (ß-tricalcium phosphate (>90%)/hydroxyapatite(<10%)). It is Conformité Européenne (CE) marked as bone void filler and bone haemostasis implant. Unlike most other synthetic bone grafts which are only osteoconductive, AttraX Putty is both osteoconductive and osteoinductive. Moreover, AttraX® Putty could overcome the disadvantages of using autologous bone grafts and allografts, such as, donor site morbidity, increased surgical time, and disease transmission. Animal studies and a clinical study showed no difference in bone fusion between AttraX® Putty and autograft after instrumented thoracolumbar fusion.
Objectives: 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 surgical accuracy, and the occurrence of (serious) adverse events.
Study design: Single-blinded, prospective, randomized controlled trial.
Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy. A total of 40 patients will be included, 20 patients in the control group (without gap filler) and 20 patients in the AttraX Putty group (with AttraX® Putty as gap filler). Osteotomy in combinations with cartilage treatment and corrections above 10 mm will be excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The mean NRS pain score
时间窗: First week postoperative daily score
Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.
次要结局
- Union rate(+1 months, +4 months, +6months, and +12 months)
- Postoperative NRS pain score(After surgery (second week daily score), +1 months, +3months)
- Rehabilitation time(After surgery (+2 weeks, +1 months, +3 months, +6 months, +1 year))
- Reduction of local blood loss(Before surgery and a weekly home measurement up to and including 1 month after surgery.)
研究者
R.J.H. Custers
Principal investigator
UMC Utrecht