Evaluating the ADEPTH sensor for measuring bore depth in bone surgeries
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures: a Monocenter Randomized Pilot Study
NA · SLAM Ortho B.V. · NCT05960591
This study is testing a new sensor to see if it makes measuring the depth of bone during surgery easier and more accurate compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SLAM Ortho B.V. (industry) |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT05960591 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the usability of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures. Participants will be randomly assigned to receive either measurements using the ADEPTH sensor or a traditional manual depth gauge. After performing three operations with each method, both the surgeon and the operating room assistant will complete surveys to evaluate the usability of the ADEPTH sensor. The study focuses on various elective plate osteosynthesis procedures involving different bones.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing elective plate osteosynthesis procedures for fractures or related conditions.
Not a fit: Patients with bone diseases or those requiring corrective surgery after previous osteosynthesis procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of bore depth measurements in orthopedic surgeries, leading to improved patient outcomes.
How similar studies have performed: While the specific use of the ADEPTH sensor is novel, similar studies evaluating new measurement technologies in surgical settings have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elective plate osteosynthesis procedure (clavicula, humerus, radius, ulna, femur, tibia, fibula, malleoli) (incl. delayed union, nonunion, malunion) * Needed surgical instrument net: 2.4 / 2.7 / 3.5-4.0 / 4.5-5.0-6.5 * Adults (≥ 18 years) * Written informed consent by patient Exclusion Criteria: * Bone disease (dysplasia's, sarcomas, chondroma's, osteolysis, osteomyelitis) * Variable angle plates * Corrective surgery after previous plate osteosynthesis procedure or hardware removal
Where this trial is running
Rotterdam, Zuid-Holland
- Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Rowan van der Peet, MSc
- Email: rowanvanderpeet@slamortho.com
- Phone: 0614308291
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.
Conditions: Fractures, Bone, Osteosynthesis