Bone Avascular NecrosisNCT00006130
Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
A study testing Core decompression in people with Bone Avascular Necrosis and Sickle Cell Anemia, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Bone Avascular Necrosis, Sickle Cell Anemia
- What is being tested?
- Core decompression
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 1999to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-sickle cell arthropathies
- Concurrent chronic steroids
- Chronic transfusion therapy
- Alcoholism
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599-7070
Children's Hospital of Oakland
Oakland, California, 94609
About this study
Official title: Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
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.
Read the 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.
- Conditions
- Bone Avascular Necrosis, Sickle Cell Anemia
- Being tested
- Core decompression
- Keywords
- arthritis & connective tissue diseases, avascular necrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, hematologic disorders, pain, rare disease, sickle cell anemia
- Medical subject headings
- Osteonecrosis, Anemia, Sickle Cell, Arthritis, Connective Tissue Diseases, Genetic Diseases, Inborn, Hematologic Diseases, Pain, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core decompressionProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2000 (estimated)
- Study startJun 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Avascular NecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- UCSF Benioff Children's Hospital Oakland
- Sponsor type
- University, hospital or other
- Investigators
- Elliott P. Vichinsky, Study chair, UCSF Benioff Children's Hospital Oakland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006130
- Sponsor's protocol ID
- NCRR-M01RR01271-5715
- Other IDs
- UNCCH-GCRC-1375
- Status last verified
- Feb 2017
- First submitted
- 3 Aug 2000
- Last updated
- 15 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00006130
- Acronym / sponsor ID
- NCRR-M01RR01271-5715
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
- Study start
- Jun 1999
- First posted
- 4 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Non-sickle cell arthropathies
- Concurrent chronic steroids
- Chronic transfusion therapy
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core decompression | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott P. Vichinsky study chair
UCSF Benioff Children's Hospital Oakland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core decompression in people with Bone Avascular Necrosis and Sickle Cell Anemia, run by UCSF Benioff Children's Hospital Oakland at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.