A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
University medical center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
R.J.H. Custers, Dr
r.j.h.custers@umcutrecht.nl
088 7558327
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
Experimental: Putty
The osteotomy gap will be filled with a synthetic ceramic material, Putty
Placebo_comparator: Conventional
Osteotomy performed according to the conventional method, without gap filler
Sponsors
Leads: UMC Utrecht

This content was sourced from clinicaltrials.gov