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…
ID
Source
Brief title
Condition
- Other condition
- Joint disorders
Synonym
Health condition
Standsafwijking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the mean NRS pain during the first week
postoperative.
Secondary outcome
The secondary study endpoints are faster accelerated rehabilitation/regaining
function, reduction of local blood loss, accelerated, bone union, and
comparable surgical feasibility
Background summary
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.
Study 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, and comparable surgical feasibility.
Study design
Single-blinded, prospective, randomized controlled trial.
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).
Study burden and risks
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.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1. Patients above 18 years with an indication for an open-wedge osteotomy of
the femur, tibia or double level due to unicompartimental OA.
2. Comply with all aspects of the treatment, including CT scans, Xrays and
1-year follow-up
3. Informed consent
Exclusion criteria
1. Osteotomy for indication of cartilage treatment or other knee surgeries than
unicompartimental OA
2. Correction using an open wedge above 10 mm
3. Pregnant women at the time of enrolment or women who are planning to become
pregnant during the duration of the study
4. Inability to communicate in Dutch or English
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov |
| CCMO | NL84534.041.23 |