Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03359109
Other study ID # 17-004970
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date September 2024

Study information

Verified date October 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Slightly elevated blood metal levels have been found in adults undergoing hip and knee replacement. It is unknown whether pediatric patients with metal implant(plates/screws/rods) have elevated blood metal levels. This may have an impact on practice if children have high blood metal levels with routine orthopedic implants. If researchers find elevated metal levels, they may recommend patients to have the plates removed or may switch to a different type of metal. Further work on this topic is needed.


Description:

Metal implants are routinely placed in children for treatment of fracture or deformity. Long-term effects of indwelling metal implants are not well-understood. Data from this study will provide guidances as to whether some metals are safer for children (stainless vs. titanium alloys). In addition, we will document the presence of serum ion concentration for children with metal implants in place and whether this resolves after implant removal. Tissues adjacent to implants will be evaluated for signs of metallosis and wear debris. Presence of metallosis will be correlated with serum ion concentration. In vivo studies will provide data on whether metal exposure to bone cells and fibroblasts affects their inflammatory cascade and function. Based on these findings, surgeons can better counsel patients whether routine implant removal is advisable or whether stainless steel implants are safer for long-term retention compared to titanium implants. Further, novel drug targets for treatment and prevention of metallosis will be developed. This project will foster collaboration and future partnerships between the Sanford Health and Mayo Clinic research teams


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 18 Years
Eligibility Inclusion Criteria: - Ages 4 years - 18 years - Stainless steel, titanium or titanium-alloy based implants, scheduled for surgery - De novo surgery where titanium implant placement Exclusion Criteria: - Concomitant infection

Study Design


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota
United States Sanford Health Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mechanistic responses of bone repair cells upon Ti exposure To address how deregulated bone repair provokes adverse reactions, the investigators will monitor gene regulatory effects in cell culture models of titanium exposure by either silencing or activating key biological pathways 3-6 months
Secondary Evaluate serum levels of metal ions To evaluate systemic effects of metal ions on children, the investigators will determine whether metal ion levels are elevated in participants with retained implants by intraoperatively blood draw and at first postoperatively visit. Conversely, participants undergoing implant placement will also have ion levels taken intraoperatively and then at latest follow-up visit to see if implants cause in increase in serum metal levels 3-6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05864833 - METabolism After Orthopedic Surgery
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Recruiting NCT05461326 - Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT N/A
Completed NCT06080685 - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents N/A
Not yet recruiting NCT06326827 - In'Oss™ (MBCP® Putty) Ortho
Not yet recruiting NCT06002009 - SupraScapular Cuff Study: Assessing the Effects of Size and Type of Rotator Cuff Tear on Suprascapular Nerve Function
Completed NCT04730115 - Evaluation of Architectural Changes in Mandibular Bone Pattern After Functional Treatment by Fractal Dimension Analysis
Withdrawn NCT03436667 - Perioperative Factors Impacting Surgical Risk and Outcomes in Children
Completed NCT03299920 - Opioid Consumption After Knee Arthroscopy N/A
Active, not recruiting NCT05075525 - EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME N/A
Completed NCT06158165 - Evaluating The Cardiovascular Effects of Tourniquet Application
Recruiting NCT04891549 - Tension Band Versus Locking Plate Fixation for the Treatment of Patella Fractures N/A
Recruiting NCT04676841 - Wound Contamination During Orthopaedic Surgery
Not yet recruiting NCT03899298 - Safety and Clinical Outcomes With Amniotic and Umbilical Cord Tissue Therapy for Numerous Medical Conditions Phase 1
Completed NCT04514601 - A Quality Improvement Project to Assess and Refine the Handover Process at Morning Trauma Meetings
Not yet recruiting NCT04546594 - Epidemiological Data on Pain
Completed NCT05396924 - Rectal Temperature Measurement in Detecting Hypothermia During Hip Arthroscopy N/A
Active, not recruiting NCT06438835 - Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO) N/A
Active, not recruiting NCT05795127 - Risk for Reoperation After First MTP Joint Arthrodesis
Completed NCT04481711 - Total Knee Arthroplasty and Clinical Findings N/A

External Links