To investigate the safety and performance of a patient-matched injection molded Bionate ® II 80A radiocarpal interposition arthroplasty implant in adult patients with posttraumatic radiocarpal osteoarthritis.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety of a patient-matched injection molded Bionate ® II 80A radiocarpal
interposition arthroplasty implant in adult patients with posttraumatic
radiocarpal osteoarthritis.
Evaluation of the safety of the use of radiocarpal interposition arthroplasty
implant will be performed throughout the clinical investigation by reporting
the number of patients with adverse events (AE) observed during the study, and
in specific AE timing, nature, severity and relatedness to the study device or
procedure.
Secondary outcome
To evaluate the performance of a patient-matched injection molded Bionate ® II
80A radiocarpal interposition arthroplasty implant in patients with
posttraumatic radiocarpal osteoarthritis.
Evaluation of the performance of the radiocarpal interposition arthroplasty
implant will be performed throughout clinical investigation by evaluating
patient reported outcome measures (PROMs) for functional outcomes, pain, and
functionality of the radiocarpal joints, measured as range of motion and grip
strength. In addition, radiocarpal cartilage and luxation of the radiocarpal
interposition arthroplasty implant will be evaluated by MRI.
Background summary
Hand and wrist injuries account for approximately 20% of all visits to Dutch
emergency departments and are the most expensive of all type of injuries
presenting at emergency departments.
Normal wrist movement requires proper functioning of the distal radio-ulnar and
radiocarpal joint. The distal radio-ulnar joint is responsible for pronation
and supination while the radiocarpal joint is responsible for flexion,
extension, radial and ulnar deviation.
A possible consequence of severe wrist trauma is posttraumatic wrist
osteoarthritis, which can lead to severe functional impairment and pain.
Especially the radiocarpal joint, formed by the distal radius, scaphoid and
lunate, is susceptible to severe posttraumatic osteoarthritis in case of prior
serious trauma. Available surgical techniques for treatment of severe
posttraumatic osteoarthritis of the radiocarpal joint include excisional
arthroplasty (proximal row carpectomy), limited and total wrist fusion and
partial or total arthroplasty.
Long-term outcomes of proximal row carpectomy are disappointing, especially
among patients involved in manual labour. Functional outcomes after total wrist
arthrodesis are worse compared to total wrist arthroplasty, although these
findings were not supported by large numbers in literature. Long-term results
of wrist arthroplasty for posttraumatic degenerative conditions are not
available among large cohorts of patients and this technique is preferably used
for rheumatic conditions of the wrist joint
A possible solution for treatment of severe symptomatic posttraumatic
degenerative wrist conditions may be surgery performing interposition
arthroplasty. Both autologous tissues and artificial materials have been used
for the construction of interposition arthroplasties.
We want to investigate, in a first-in-human clinical investigation, the safety
and performance of a patient-matched injection molded Bionate ® II 80A
radiocarpal interposition arthroplasty in adult patients with posttraumatic
radiocarpal osteoarthritis. The used product will be the WISE implant for
Radiocarpal Interposition Arthroplasty.
Study objective
To investigate the safety and performance of a patient-matched injection molded
Bionate ® II 80A radiocarpal interposition arthroplasty implant in adult
patients with posttraumatic radiocarpal osteoarthritis.
Study design
This is a prospective single-centre interventional open-label pilot study in a
single group of twelve (12) patients with the focus on safety and performance
of a patient-matched injection molded Bionate ® II 80A radiocarpal
interposition arthroplasty implant for posttraumatic osteoarthritis of the
radiocarpal joint.
In general, safety and performance will be evaluated during hospital stay, at 2
and 6 weeks, 3 and 6 months, and at 1 year after surgery. If additional
evaluations are necessary for safety or performance issues between study visits
these will be performed as unscheduled visits. If the implant is still in place
and giving no complaints at 1 year follow up, the evaluations will be extended
until removal of the implant. The patient will be asked additional informed
consent for the extended follow up period. If applicable a protocol amendment
will be submitted to ask ethics approval for this protocol extension.
Intervention
surgery performing interposition arthroplasty using the WISE implant for
Radiocarpal Interposition Arthroplasty.
Study burden and risks
Possible additional risks to participating in this study are next to the
standard risks of having surgery:
-infection
-rotation of implant
-dislocation or displacement
-pain
-other risks of the use of the WISE implant not nown so far
Burden of participation:
-6 times blooed tests
-3 MRI's
-radiation burden of 1 additional wrist CT
-1 day hospitalisation
p Debyelaan 25
Maastricht 6229 HX
NL
p Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Signed and dated written informed consent prior to admission to the clinical
study in accordance with good clinical practice (GCP) and local legislation;
- Male >18 years of age and post menopausal females;
- Diagnosed with posttraumatic radiocarpal osteoarthritis as diagnosed with an
X-ray and/or CT scan of the wrist;
Exclusion criteria
- Previous surgery for posttraumatic radiocarpal osteoarthritis, with in
particular salvage procedures such as excisional arthroplasty (proximal row
carpectomy), total wrist arthrodesis and total wrist arthroplasty; Prior
reconstructive procedures are not exclusion criteria;
- General objections for surgery, determined after anaesthesiologic
assessment;
- Radiocarpal osteoarthritis including the midcarpal joint;
- Acute or chronic infection of the radiocarpal joint;
- Diagnosed rheumatoid arthritis of the radiocarpal joint;
- Unwilling to cooperate with the study protocol and follow up schedule;
- Judged by the surgeon mentally incapable to follow study requirements;
- Diagnosed with neuromuscular or neuro-sensory deficit which would limit the
ability to assess the performance of the radiocarpal interposition arthroplasty;
- Diagnosed with active malignancy;;
- Known systemic or metabolic disorders leading to progressive bone
deterioration;
- Use of systemic corticosteroids within the last 3 months (inhaled steroids
are no reason for exclusion);
- Presence of an active or suspected infection;
- Uncontrolled diabetes mellitus as determined by treating physicians;
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 | NL81056.000.22 |