NCT07095244 Pediatric Outcomes and Recovery With Peri-Operative Iron Supplement Evaluation
| NCT ID | NCT07095244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Varus-Derotation Osteotomy Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2025-09-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Varus-derotation osteotomy (VDRO) is a surgery to prevent or address hip displacement in children. Many children having this surgery have cerebral palsy or other neuromotor disorders, who have a higher rate of malnutrition, including low iron or anemia. This can affect their surgical outcomes, such as increasing their need for blood transfusions. This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions. This may include taking iron supplementation for patient with low iron or anemia. Participants will undergo a nutrition program before their surgery.
Eligibility Criteria
Inclusion Criteria: * All patients scheduled for VDRO and/or pelvic osteotomy surgery (prospective cohort) * All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 (historical cohort) * Ages 0-18 years old Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. The investigators may not include patients who are enrolled in other conflicting research studies. Exclusion Criteria: * Patients who have undergone a major surgical intervention in the last 3 months * Patients who have received a nutritional intervention that includes iron testing and treatment within the last 3 months * Patients in whom oral/enteral iron supplementation is contraindicated * Patients who have a bleeding disorder * Patients taking erythropoietin * Patients who cannot read and understand English\* * Patients and their families who cannot read and understand English will be excluded from the study because the surveys and interviews are conducted in English. These patients will still have access to the same nutrition management and interventions as study participants.
Contact & Investigator
Teresa Skelton, MD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT07095244 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Varus-Derotation Osteotomy Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07095244 currently recruiting?
Yes, NCT07095244 is actively recruiting participants. Contact the research team at steffanie.fisher@bcchr.ca for enrollment information.
Where is the NCT07095244 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT07095244 clinical trial?
NCT07095244 is sponsored by University of British Columbia. The principal investigator is Teresa Skelton, MD at University of British Columbia. The trial plans to enroll 180 participants.