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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06429267
Other study ID # 6360
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 26, 2024
Est. completion date April 2026

Study information

Verified date May 2024
Source Louisiana State University Health Sciences Center in New Orleans
Contact Sylvia Culpepper, MS
Phone 2283270278
Email sculpe@lsuhsc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a prospective randomized controlled trial comparing the clinical outcomes of bioabsorbable screws to conventional metal screws in pediatric patients (aged 0 to 18) undergoing surgical fixation for trauma or elective procedures. Conducted by the pediatric orthopedic department at Children's Hospital New Orleans, the study aims to evaluate the effectiveness of these screws in bone healing over key post-operative intervals (6 weeks, 6 months, and 1 year). It seeks to determine if bioabsorbable screws offer significant advantages over metal screws in terms of reducing the need for secondary surgeries, based on their hypothesized noninferiority in complication rates. Participants will be randomly assigned to receive either bioabsorbable or metal (titanium or stainless steel) screws after obtaining informed consent from a parent or guardian.


Description:

This study is a prospective randomized controlled trial to evaluate clinical outcomes associated with the use of bioabsorbable screws compared to conventional metal screws in children aged 0 to 18 who are undergoing surgical fixation in the setting of trauma such as medial epicondyle fractures of the elbow or elective procedures. The research will be conducted within the pediatric orthopedic department at CHNOLA, and participants will be assessed at key intervals, including 6 weeks, 6 months, and 1 year post-operation post-operation. The primary objective of this study is to assess and compare the effectiveness of conventional metal screws and bioabsorbable screws in bone healing. This study aims to determine whether bioabsorbable screws are significantly superior to conventional titanium screws. The investigators hypothesize bioabsorbable screws are significantly noninferior to conventional metal screws in terms of complications based on prior surgical constructs that demonstrate bioabsorbable screws eliminate the need for a second surgery After informed consent has been obtained from the parents of patients, eligible patients undergoing cannulated screw fixation will be randomized into two groups: one group who will receive bioabsorbable screws and the other group who will receive metal screws (titanium or stainless steel).


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Primary fractures requiring fixation with cannulated screws Exclusion Criteria: - Children ten years old or under with a fracture requiring screws to be fixed across the growth plate (physis) - Secondary fractures - Non-union fractures - Tibial tubercle osteotomies (TTOs) - Slipped capital femoral epiphysis (SCFEs) - Unable or unwilling to provide informed consent or parental/guardian consent for participants under 18 years of age - Allergies or contraindications to screw materials

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Bioabsorbable Screw
Bioabsorbable screw that redissolves into the bone. Mineral fibers are composed of Silicon Dioxide (SiO2), Sodium Oxide, Calcium Oxide, Magnesium Oxide, Boron Trioxide, and Phosphorous Pentoxide
Metal/Titanium Screw
Traditional metal screw used in fracture fixation that requires hardware removal

Locations

Country Name City State
United States Children's Hospital New Orleans New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Louisiana State University Health Sciences Center in New Orleans

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Computer Adaptive PROMIS (Patient-Reported Outcomes Measurement Information System) Surveys Pain, Upper Extremity and Mobility. These questionnaires are scored using T scores. For pain, a higher score is a worse outcome. For mobility and upper extremity, a lower score is a worse outcome. Min value is 0 and max is 100 for all. 6 weeks, 6 months, 1 year
Secondary Complications Any complications of surgery (infection etc) 1 year
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