Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-02
Brief Title:
Spica Cast Duration for DDH
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Prospective Analysis of Optimal Spica Cast Duration Following Closed Reduction for Developmental Dysplasia of the Hip DDH
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study looks at treatment for developmental dysplasia of the hip DDH a condition where there is abnormal development of a childs hip joint While spica casts are shown to very effective in treating DDH and potentially more effective than hip braces alone other research shows that the outcomes from braces are equivalent to those of spica casts with the added advantage of greater patient satisfaction and less burden on families Therefore the 12-week experimental protocol in the study with the first 6 weeks involving the spica cast and the second 6 weeks the hip brace was designed to determine if both treatment methods can be combined for an optimal patient experience
Detailed Description:
The primary objective of this study is to compare the clinical outcomes of patients who undergo closed reduction of a developmentally dysplastic hip and are treated with six weeks of supplemental casting to those treated with twelve weeks of supplemental casting
The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway 12 weeks of spica casting
The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress Following 6 weeks of recovery the control group will have their spica cast replaced in the operating room with the child anesthetized by another cast for 6 weeks The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks Participants will be instructed to complete the full 12 weeks of the protocols Only patients who complete the full length of treatment in either group will be considered for the study The physicians will keep track of patients during visits to ensure the protocols are being followed
The secondary objectives of this study are to determine if a shorter duration of postoperative casting affects family satisfaction and costs compared to the traditional pathway 12 weeks of spica casting
The physician will meet with the patients during the regular standard of care follow-ups every 2-3 weeks to track patient progress Following 6 weeks of recovery the control group will have their spica cast replaced in the operating room with the child anesthetized by another cast for 6 weeks The experimental group will have their cast removed in the clinic without anesthesia and will be placed into a full-time brace for 6 weeks Participants will be instructed to complete the full 12 weeks of the protocols Only patients who complete the full length of treatment in either group will be considered for the study The physicians will keep track of patients during visits to ensure the protocols are being followed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000 | OTHER | CTGTY | None |