| Protocol ID | NCT07111858 |
| Registration Date | 2025-08-08 |
| Status | recruiting |
| Sponsor | Maidstone & Tunbridge Wells NHS Trust |
| Country | United Kingdom |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2023-08-02 |
| Last Patient Out | 2027-06-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 0 Weeks - 16 Weeks |
NCT07111858
Pavlik Harness Treatment Versus Monitoring for Treatment of Graf Type 2b and 2c Hip Developmental Dysplasia of the Hip (DDH)
| Field |
GLM
glm-5.1 8449ms / 11137 tok |
OPENAI
gpt-4o 2327ms / 10964 tok |
CLAUDE
claude-sonnet-4-20250514 5816ms / 12602 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention involves outpatient clinic visits for ultrasound monitoring, harness fitting, and regular check-ups at a hospital trust, but does not require the babies to be hospitalized or admitted as inpatients.
|
other
other → other
shaky reasoning✓ Unanimous
Initial: other
Requery: other — The intervention comprises outpatient clinic visits and ultrasound scans, not requiring hospitalization or inpatient care.
|
other
hospital → other
shaky reasoning✓ Unanimous
Initial: hospital
Requery: other — The intervention is delivered primarily through outpatient specialty clinics at a hospital trust for regular ultrasound scans and harness fittings/monitoring, not requiring inpatient admission.
|
OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no | no | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial compares Pavlik harness treatment versus watchful waiting for hip dysplasia; ultrasounds are used for diagnosis, eligibility assessment, and outcome measurement, not as the screening intervention itself.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial is not testing a screening intervention; screening ultrasound is used for assessment and monitoring, not as the primary intervention being evaluated.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention being tested is watchful waiting versus Pavlik harness treatment for hip dysplasia, not a screening tool to identify palliative care needs.
|
OK |
| intervention_palliative | no | no | no | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | yes | yes | yes | OK |
| outcome_symptom | no | no | no | OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |