To confirm the safety of the Articulinx implant by evaluating device and procedure related adverse events.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of device and procedure related adverse events.
Secondary outcome
Average pain score post procedure compared to pre operative baseline.
Change in pain medication use ( taken specifically for the hand) compared to
pre operative baseline.
Change in joint function post procedure compared to pre operative baseline.
Background summary
A clinical need exists for an early treatment of osteoarthritis of the hand
that mitigates pain and restores biomechanics without drugs or radical surgery.
Articulinx Inc. has developed an alternative treatment for Osteoarthritis of
the hand. The implant is designed to be inserted into the CMC joint of the
hand, restoring the space between the the joint surfaces without disrupting
joint architechture or removing supporting bone or soft tissues. A simple
minimally invasive procedure is required to insert the implant. The Articulinx
implant is designed to be implanted earlier in the disease process, allowing a
more active lifestyle and potentially reducing or eliminating the need for long
term use of prescription medications.
Study objective
To confirm the safety of the Articulinx implant by evaluating device and
procedure related adverse events.
Study design
A non randomised, prospective, non controlled study.
Intervention
Minimally invasive surgical procedure.
Study burden and risks
Not applicable.
1601 S. De Anza Blvd., Suite 215
CA 95014, Cupertino
US
1601 S. De Anza Blvd., Suite 215
CA 95014, Cupertino
US
Listed location countries
Age
Inclusion criteria
Adults between ages 40-75 with stage I or II osteoarthritis (according to Eaton Littler classification) of the CMC I joint. Subluxation less than 1/3 of the joint. Patients who are capable of providing informed consent and willing to adhere to the follow up schedule.
Exclusion criteria
Significant and affecting pathology of the radial side of the hand and wrist.
Significant osteophytes of the CMC I joint.
Metabolic disorders of the bone.
Prior surgery that precludes placement.
Participating in another study.
Pregnancy and lactation.
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 | NL28895.029.09 |