Evaluation of the LatellaTM Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
- Conditions
- arthritis on the inner side of the kneeMedial osteoarthritis1002321310005944
- Registration Number
- NL-OMON44456
- Lead Sponsor
- Cotera Inc.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
- History of pain for at least 6 months due to medial osteoarthritis, with failure
of pain relief from non*operative therapy OR from arthroscopic treatment for
medial osteoarthritis (see exclusion criteria for excluded procedures)
- Age: 30 * 70 years
- Weight: Less than 136 kg
- Kellgren*Lawrence scores: Grades 2*3
- Baseline KOOS pain score of * 60
- Baseline medial knee pain Numerical Rate Scale (NRS) (while walking) score * 4
- Willing and able to understand and sign the informed consent
* Varus angle > 10 degrees (mechanical axis)
* Active Flexion > 140 degrees
* Joint flexion contracture > 10 degrees
* Contralateral knee pain (Baseline medial knee pain NRS (while walking) score * 3)
* Osteoporosis or other condition (e.g., hyperthyroidism, Paget*s disease, scurvy) that could compromise bone quality
* Permanent implant in or around the knee joint
* Rheumatoid arthritis
* Osteoarthritis in non-knee joint of the lower limb or lower back that impacts activities of daily living
* Immunosupressive disorders (e.g., diabetes)
* Chronic (6 months or longer) steroid use (with the exception of inhaled steroids)
* History of heterotopic ossification
* Ligament instability
* Joint instability
* Symptomatic evidence of moderate to severe OA in the lateral and/or patellofemoral compartments
* Lateral osteophytes that would underlie implant region (diagnosed via x-ray)
* Free floating bodies
* Post-traumatic osteoarthritis
* Arthroscopy within the last 3 months
* Meniscal debridement within the last 6 months
* Prior anterior cruciate ligament reconstruction
* Tight Iliotibial Band or Iliotibial Band Syndrome
* Femoral or tibial bony deformity
* Disease affecting the connective tissue or muscle
* Continued participation in competitive or high-impact sports (e.g.,Tegner score >6)
* Less than 5 year history free of cancer
* Less than 5 year history free of primary bone tumors
* History of stroke, upper limb or lower limb motor disorders
* Bleeding diathesis
* Chronic use of anticoagulants (with the exception of aspirin)
* Known metal ion allergy to titanium alloy, aluminum, or vanadium alloy
* Absolute or relative contraindication for MRI
* Substance abuse (drug or alcohol)
* For women of childbearing potential: pregnant, or planning to become pregnant during the course of the clinical investigation
* Litigation for or workers compensation for musculoskeletal injuries or disorders
* Are currently participating in, or have been recently exited from (within 30 days of enrollment in this study), or plan to be enrolled in another clinical study for a device or drug that may impact participation or outcome of this study
* Has a condition, disorder or other factor that, in the investigator*s opinion, would interfere with study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint is the mean change in KOOS pain score at 6 Months<br /><br>after treatment with the Latella Implant.<br /><br><br /><br>The primary safety endpoint is the surgical re-intervention rate during the 6<br /><br>Month period following implantation of the Latella device.</p><br>
- Secondary Outcome Measures
Name Time Method