The purpose of the investigation is to confirm the safety and efficacy of the InDx implant in treatment of CMC osteoarthritis.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint: adverse events related to the device which lead to a
total revision.
Primary endpoint efficacy: outcome functional performance per DASH and PRWHE
questionnaires.
Secondary outcome
Secondary endoints:
- Thumb ROM
- Pinch force (tip pinch and latral pinch)
- Grip force
Also see section 4.2 of the CIP.
Background summary
Carpometacarpal (CMC) osteoarthritis (OA), particularly prevalent in
postmenopausal women over 65. CMC osteoarthrosis is a degenerative condition
causing pain, stiffness, and weakness. It affects a significant portion of the
elderly population, with 17-33% of elderly women and 5-11% of men showing
evidence of CMC OA. Severe thumb base arthritis impacts 5% of the population,
translating to over 40 million people in the US and EU alone.
Besides the symptoms as described above, CMC osteoarthrosis symptoms also
include reduced motion range of the thumb and decreased grip and pinch
strength, hindering daily activities.
Treatment options vary from conservative approaches (lifestyle change, physical
therapy, splinting, medication) to a surgical intervention. The most common
intervention is a trapeziectomy, in which the trapezium is removed.
Disadvantages in general are reduced range of motion of the thumb and a
decrease in force and functionality of the hand. A substantial decrease in pain
is not always achieved. Total- or hemiarthroplasty procedures are also done
with a number of devices which are already on the market, but treatment with
these devices also has it's disadvantages (see section 1.1 of the CIP).
The InDx implant is designed to accomodate the natural biomechanics of the
thumb joint, aiming for a stable fixation within the joint to prevent loosening
or subluxation.
Study objective
The purpose of the investigation is to confirm the safety and efficacy of the
InDx implant in treatment of CMC osteoarthritis.
Study design
This is a prospective, multi-center non-comparative study.
Intervention
The intervention is a hemiarthroplasty with the InDx implant, instead of a
trapeziectomy. The subjects would have been scheduled for a surgical
intervention anyway.
Study burden and risks
The study participants were already eligible for surgical intervention due to
complaints regarding thumb base arthritis. The most common intervention
(trapeziectomy, removal of the trapezium) has a number of disadvantages and the
outcome usually includes limitations of hand functionality and non-substantial
decrease of pain. Treatment with the InDx implant could provide a possible
improvement.
The additonal burden to the subjects are addtional tests for grip and pinch
strength and addtional questionnaires. There no addtional invasive tests
required.
The riscs as described in section E9 are mitigated bu thourough training of the
surgeons and frequent follow-up after the surgery. Most risks that are directly
linked to the implant can be reversed by performing a trapeziectomy in extreme
cases after removal of the implant.
Unit 4, Business Innovation Centre, NUI Galway 4
Galway H91 H2Y0
IE
Unit 4, Business Innovation Centre, NUI Galway 4
Galway H91 H2Y0
IE
Listed location countries
Age
Inclusion criteria
A. The patient is at least 18 years of age;
B. The patient has a confirmed Grade I-III osteoarthritis of the CMC joint on
clinical examination and X-ray;
Exclusion criteria
A. The patient is suffering from Rheumatoid arthritis in the index hand;
B. The patient is suffering from Grade IV osteoarthritis of the CMC joint;
C. The patient is suffering post-traumatic arthritis of the CMC joint in the
index hand;
D. The patient is a pregnant/lactating female (tested as per institutional
requirements);
E. Active or latent infection, or sepsis;
F. Insufficient quantity or quality of bone and/or soft tissue in the index
hand;
G. Metal or polymer material sensitivity;
H. Muscular imbalance, peripheral vascular disease that prohibits adequate
healing, or a a poor soft-tissue envelope in the surgical field, absence of
musculoligamentous supporting structures, or peripheral neuropathy;
I. Patient with previous thumb surgery in the index hand
J. In the opinion of the investigator, any medical condition that makes the
subject unsuitable for inclusion in the study, including, but not limited to
a. Patients with a diagnosis of concomitant injury that may interfere with
healing
b. Patients with clinically significant renal, hepatic, cardiac, endocrine,
hematologic, autoimmune, or any systemic disease or systemic infection that may
make interpretation of the results difficult
K. Patients who have undergone systemic administration within 30 days prior to
implantation of any type of corticosteroid, antineoplastic, immunostimulating,
or immunosuppressive agents;
L. Comorbidity that reduces life expectancy to less than 36 months;
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 | NL86290.000.24 |