Manual Intervention and Congenital Hip Dysplasia in Infants (NCT07756814) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Manual Intervention and Congenital Hip Dysplasia in Infants
30 participantsStarted 2026-08
Plain-language summary
Developmental dysplasia of the hip (DDH) is a developmental abnormality of the infant hip in which the acetabulum does not adequately cover the femoral head. Standard conservative treatment commonly includes a Pavlik harness. This exploratory randomized pilot study will assess whether a gentle manual intervention applied to the coxal bone, in addition to conventional orthopedic treatment, is associated with a greater change in ultrasound-measured femoral head coverage than conventional orthopedic treatment alone. Thirty infants aged 1 to 5 months with confirmed unilateral or bilateral DDH (Graf IIa to III) will be randomized to two parallel groups. The experimental group will receive one manual intervention session per week for three consecutive weeks in addition to conventional orthopedic treatment. The comparison group will receive conventional orthopedic treatment alone. Ultrasound assessments will be performed at baseline (T0) and after the intervention period (T1). In infants with bilateral DDH, both dysplastic hips will be evaluated at both time points and recorded separately. A secondary objective is to describe parental acceptability of the manual intervention and study procedures. As a pilot study, the project is intended to provide preliminary information on the direction and variability of the intervention effect, parental acceptability, and study feasibility to inform a future larger trial.
Who can participate
Age range
1 Month – 5 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of DDH, unilateral or bilateral
* Graf score between IIa and III (moderate to severe DDH), as stage I may resolve spontaneously
* Written parental authorization (or delegated parental representation) providing free and informed consent
* Infant already receiving conservative orthopedic care with a Pavlik harness (the study tests a complementary intervention)
* Parental availability for the study follow-up
Exclusion Criteria:
* Presence of severe congenital anomalies
* Neuromuscular or genetic diseases affecting muscle tone or bone growth
* Cardiorespiratory conditions requiring constant monitoring
* Fractures of the pelvis or lower limbs
* Prematurity (birth before 37 weeks of gestation)
* Medical contraindications to the proposed manual intervention
* Ongoing physiotherapy or any manual therapy treatment outside the study framework
* Growth retardation (staturo-ponderal), with or without suspected nutritional deficiencies
* Infant showing distress or intolerance to physical handling during prior care
* Simultaneous participation in another clinical study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Coverage of the femoral head/epiphysis by the acetabulum
Timeframe: From enrolment to end of treatment represent about 4 weeks for each participant