To confirm the safety of the Articulinx ICC by evaluating device- and procedure relates 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 intra-operatively,
and through two years follow-up.
Average CMC-I joint pain score post-procedure compared to pre-operative
baseline through two years follow-up.
Secondary outcome
Change in pain medication use for CMC-I joint as compared to baseline.
Change in CMC-I joint function post-procedure as compared to baseline.
Change in DASH scores as compared to baseline
Background summary
A clinical need exists for an early treatment of osteoarthritis of the hand
that mitigates pain and restores biomechanics without drug or radical surgery.
Articulinx Inc. has developed an alternative treatment for osteoarthritis of
the hand. The device is designed to be inserted into the CMC-I joint of the
hand, restoring the space between the joint surfaces without disrupting joint
architecture or removing supporting bone or soft tissues. A simple minimally
invasive procedure is required to insert the implant. The Articulinx device is
designed to be implanted earlier in the disease process, allowing a more active
lifestyle and potentally reducing or eliminating the need for long term use of
prescription medications.
Study objective
To confirm the safety of the Articulinx ICC by evaluating device- and procedure
relates adverse events.
Study design
Prospective, non-randomized, 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 35 -75 years old with osteoarthritis of the carpometacarpal (CMC-I) joint. VAS- painscore > 40 at baseline. Subluxation less than 1/3. Patients capable of providing informed consent.
Exclusion criteria
Significant and affecting pathology of the radial side of the hand and wrist.
Significant osteophytes (> 2 mm) and free floating bodies in CMC-I joint
Rheumatoid and/or Metabolic disorders of the bone.
Prior surgery.
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 | NL35822.029.11 |