Observational study on total wrist replacement outcomes with KinematX implant
The KinematX Midcarpal Total Wrist Arthroplasty: A Multicenter Prospective Registry of Clinical and Patient-Reported Outcomes
This study is testing how well the KinematX wrist replacement helps people regain movement and strength in their wrist after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Extremity Medical Industry-sponsored |
| Locations | 4 sites (Loma Linda, California and 3 other locations) |
| Trial ID | NCT05719935 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the functional and patient-reported outcomes of individuals undergoing total wrist replacement using the KinematX total wrist arthroplasty system. Participants will be monitored for a range of motion, grip and pinch strength, and various patient-reported outcomes at multiple time points, including 3, 6, and 12 months post-surgery, and annually for up to 10 years. The study will collect preoperative and postoperative data to assess changes over time and determine the effectiveness of the KinematX implant in improving wrist function.
Who should consider this trial
Good fit: Ideal candidates include adults with specific wrist conditions such as SLAC, SCAC, STTAC, carpal tunnel syndrome, or Kienbock's disease who are undergoing total wrist arthroplasty with the KinematX implant.
Not a fit: Patients under 18 or over 85 years of age, as well as those with certain contraindications or severe wrist conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and patient satisfaction associated with total wrist replacement, potentially improving treatment options for patients with wrist conditions.
How similar studies have performed: While this study focuses on a specific implant, similar observational studies on total wrist arthroplasty have shown promising outcomes, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * one of the following diagnoses and planned (or previously completed) total wrist arthroplasty with the KinematX total wrist: * osteoarthritis or post-traumatic arthritis * scapholunate advanced collapse (SLAC/SNAC wrist), * inflammatory arthritis (rheumatoid, psoriatic, other), * crystalline advanced collapse (SCAC), * STT advanced collapse (STTAC), * ulnar translocation, * Kienbӧck disease, * radial malunion Exclusion Criteria: * \<18 years of age * \>85 years of age * Prisoners * Children * Pregnant women * Contraindications to receiving the KinematX: * Local, distant or systematic acute or chronic soft tissue or bony infection * Physiologically or psychologically compromised patient * Active wrist synovitis or severe carpal bone erosion * Suspected or documented metal allergy or intolerance * Insufficient extensor tendons * Inadequate skin, bone, neural or vascular status * Severe carpal bone malalignment, displacement, absorption, neoplastic, or carpal bone pathology * Sepsis * Osteomyelitis * Uncontrolled/untreated osteoporosis or metabolic bone disease * Metabolic or endocrinologic bone disorders * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Where this trial is running
Loma Linda, California and 3 other locations
- Loma Linda University — Loma Linda, California, United States (Recruiting)
- Florida Orthopaedic Institute — Tampa, Florida, United States (Recruiting)
- Franciscan Health — Indianapolis, Indiana, United States (Recruiting)
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Brian Smekal
- Email: bsmekal@extremitymedical.com
- Phone: +1 952-836-5698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.