The objective of this study is to investigate whether reconstruction of the radiocarpal joint by implantation of a tailor-made and patient specific 3D printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is feasible as a…
ID
Source
Brief title
Condition
- Bone and joint injuries
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective of this study is to investigate whether reconstruction of the
radiocarpal joint by implantation of a tailor-made and patient specific 3D
printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is
feasible as a therapy in patients with severe posttraumatic radiocarpal
osteoarthritis.
The feasibility will be measured in by evaluation of the position, aspect,
degree of wear and tear and eventual (dis)location of the Bionate® II
interpositional arthroplasty. The evaluation will be done by magnetic resonance
imaging (MRI) of the wrist at different time points in follow-up after
implantation.
Eventual negative side-effects of implantation of a Bionate® II PCU sheet in
the radiocarpal joint will be registered.
Secondary outcome
Next to radiological evaluation of the feasibility, clinical and functional
outcomes will be assessed as well. We will investigate the effect of the
Bionate® II interpositional arthroplasty on functionallity of the radiocarpal
joints, measured as range of motion and grip strength of the affected wrist
compared to baseline. We will assess the functional outcome and pain as
measured with the PRWHE, SF36 and EQ5D questionnaires. We will determine the
functional outcome at four different time points in follow-up after
implantation, compared to the situation prior to surgery. Eventually we want to
investigate whether the Bionate® II interpositional arthroplasty can serve as a
better alternative for severe posttraumatic degenerative wrist conditions than
excisional arthroplasty or wrist arthrodesis.
Background summary
Posttraumatic osteo-arthritis of the wrist, especially the radiocarpal joint,
is a possible consequence of severe wrist trauma and can lead to serious
functional impairment and pain. Clinical results of presently available
surgical techniques for treatment of posttraumatic radiocarpal osteo-arthritis
are disappointing.
A possible solution might be performing an interpositional arthroplasty. In the
past, both autologous tissues and artificial materials have been used for the
construction of interpositional arthroplasties. Interpositional arthroplasty
using silicon rubber implants in
the wrist joint has been performed since decades and short-term results are
excellent. Long-term results however are disappointing, most likely due to
limited tensile and tear strength of the available silicone implants.
Recently, a more suitable material for these indications, called Bionate® II
Polycarbonate-urethane (PCU) (DSM®), has been developed. Preliminary results
for this material in orthopedic surgery are very encouraging.
Study objective
The objective of this study is to investigate whether reconstruction of the
radiocarpal joint by implantation of a tailor-made and patient specific 3D
printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is
feasible as a therapy to reduce pain and preserve mobility of the wrist joints
in patients with severe posttraumatic radiocarpal osteoarthritis.
Study design
This study is an observational prospective single center clinical pilot study
to investigate of the feasibility of the Bionate® II interpositional
arthroplasty for posttraumatic osteoarthritis of the radiocarpal joint.
Intervention
An interpositional artroplasty is performed by inserting a small Bionate® II
PCU sheet in the radiocarpal joint via a limited dorsal wrist arthrotomy. This
procedure will be performed under general or regional anesthesia.
Study burden and risks
Patients will be submitted to physical examination at 6, 12, 24 and 52 weeks
after surgery. Physical examination consists of determination of range of
motion of the wrist joint and grip strength. Radiological evaluation will be
done by performing magnetic resonance imaging (MRI) scans of the wrist at 24
and 52 weeks after surgery. Next to physical and radiological investigation,
patients are requested to fill out 3 questionnaires preoperatively and at 6,
12, 24 and 52 weeks after surgery: The Patient Rated Wrist and Hand Evaluation
(PRWHE) questionnaire, the Short Form 36 (SF36) questionnaire and the Euroqol
5D (EQ5D) questionnaire.
Bionate® II has a long history of successful use in (joint) surgery with FDA
approval for several indications. For this study, only the form and placement
of the implant differs from Bionate® II inserts already available for and used
in clinical practice. Therefore risks associated with the implanted material
are limited.
Moreover, we expect an improved functional outcome and less surgery related
complications than presently available surgical techniques for treatment of
severe posttraumatic osteo-arthritis of the wrist joint. (like excisional
arthroplasty, total wrist arthroplasty or total wrist artrodesis)
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Patients over 18 years of age with severe post traumatic radio carpal osteo-arthritis with an indication for excision arthroplasty, arthrodesis or wrist arthroplasty will be eligible for inclusion
Exclusion criteria
Exclusion criteria are previous surgery for severe post traumatic radiocarpal conditions, especially salvage procedures (such as excisional artroplasty, arthrodesis) and general objections for surgery, determined after anaesthesiological assessment.
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 |
|---|---|
| CCMO | NL52867.068.15 |