Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006130
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2000-08-03
Brief Title:
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
UCSF Benioff Childrens Hospital Oakland
Study Overview
Official Title:
Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2017-02
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:
OBJECTIVES I Phase II trial to determine surgical morbidity of decompression coring including any adverse events in the perioperative period and the rate of secondary medical or surgical interventions
II Collect preliminary data to determine if decompression coring results in a substantial improvement in pain and mobility compared to conservative therapy in patients with avascular necrosis of the hip related to sickle cell disease
II Collect preliminary data to determine if decompression coring results in a substantial improvement in pain and mobility compared to conservative therapy in patients with avascular necrosis of the hip related to sickle cell disease
Detailed Description:
PROTOCOL OUTLINE This is a randomized multicenter study Patients are stratified according to stage of avascular necrosis I vs II vs III Patients are randomized into one of two treatment arms
Arm I Patients undergo a core biopsy and decompression of the hip followed by a standardized program of touch down or nonweight bearing with appropriate equipment and regular physical therapy for 6 weeks and then full weight bearing if tolerated
Arm II Patients undergo the standardized ambulation and physical therapy program as in arm I They do not undergo any surgical procedure
For 1 week prior to the beginning of the standardized program and during the 6 weeks of touch down or nonweight bearing all patients complete a weekly pain and medication diary
Patients are followed at 3 months and 6 months then every 6 months for 15 years and then annually for up to 5 years
Arm I Patients undergo a core biopsy and decompression of the hip followed by a standardized program of touch down or nonweight bearing with appropriate equipment and regular physical therapy for 6 weeks and then full weight bearing if tolerated
Arm II Patients undergo the standardized ambulation and physical therapy program as in arm I They do not undergo any surgical procedure
For 1 week prior to the beginning of the standardized program and during the 6 weeks of touch down or nonweight bearing all patients complete a weekly pain and medication diary
Patients are followed at 3 months and 6 months then every 6 months for 15 years and then annually for up to 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UNCCH-GCRC-1375 | None | None | None |