Clinical trial NCT00006130: Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Official title: Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Avascular Necrosis
Sickle Cell Anemia
Keywords: arthritis & connective tissue diseases
avascular necrosis
disease-related problem/condition
genetic diseases and dysmorphic syndromes
hematologic disorders
pain
rare disease
sickle cell anemia
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2000-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 1.5 years, and then annually for up to 5 years.

Eligibility criteria: Inclusion criteria:

* Diagnosis of stage I, II, or III avascular necrosis (AVN) by MRI or plain film imaging that is related to sickle cell disease
* Clinically moderate to severe pain originating from the hip and/or limitation of movement of the affected hip
* AVN in the contralateral hip allowed, regardless of stage, if the primary hip is eligible If both hips eligible, most symptomatic hip enrolled

Exclusion criteria:

* Non-sickle cell arthropathies
* Concurrent chronic steroids
* Chronic transfusion therapy
* Alcoholism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: UCSF Benioff Children's Hospital Oakland
name: Elliott P. Vichinsky
role: STUDY_CHAIR
References: