Trial document
This trial has been registered retrospectively.
DRKS00011269
Trial Description
Title
Outcome after Advanced Core Decompression
Trial Acronym
ACD
URL of the Trial
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Brief Summary in Lay Language
“Advanced Core Decompression” (ACD) is a new technique for treatment of osteonecrosis of the femoral head (ONFH) that includes removal of the necrotic tissue using a percutaneous expandable reamer followed by refilling of the drill hole and the defect with an injectable, hard-setting, composite calcium sulphate (CaSO4)-calcium phosphate (CaPO4) bone graft substitute. As autologous bone has been shown to be superior to all other types of bone grafts, the aim of the study is to present and evaluate a modified technique of ACD with impaction of autologous bone derived from the femoral neck into the necrotic defect. The aim of the study is to evaluate the clinical and radiological outcome after modified Advanced Core Decompression. The primary outcomes the hip survival rate 5 years postoperative with an annual survey. Moreover clinical parameters (Harris-Hip-score and VAS) should be evaluated. MRI will be used to evaluate the bone-remodeling and healing of the osteonecrosis
Brief Summary in Scientific Language
Clinical and radiological outcome after Advanced Core Decompression
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00011269
- 2016/11/14
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- yes
- Approved
- 10-4293, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
Secondary IDs
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Health Condition or Problem studied
- M87.95 - [generalization M87.9: Osteonecrosis, unspecified]
Interventions/Observational Groups
- Patients who suffering from osteonecrosis of the femoral head (stage ARCO I-III) undergo modified Advanced Core Decompression with addition of autologous bone (intervention).
Characteristics
- Interventional
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- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Treatment
- Single (group)
- IV
- No
Primary Outcome
Hip survival rate 5 years postoperative.
Annual survey.
Secondary Outcome
Clinical and radiological outcome 5 years postoperative.
Annual survey.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2010/11/01
- 200
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 80 Years
Additional Inclusion Criteria
Stage ARCO 1-3
Exclusion Criteria
Stage ARCO 4 and higher.
Osteoarthritis
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Essen
- Mr. Priv.-Doz. Dr. med. Stefan Landgraeber
- Hufelandstraße 55
- 45147 Essen
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- 0201/4089-2261
- 0201/4089-2722
- stefan.landgraeber at uni-due.de
- http://www.uniklinikum-essen.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universitätsklinikum Essen
- Mr. Priv.-Doz. Dr. med. Stefan Landgraeber
- Hufelandstraße 55
- 45147 Essen
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0201/4089-2261
- 0201/4089-2722
- stefan.landgraeber at uni-due.de
- http://www.uniklinikum-essen.de
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universitätsklinikum Essen
- Mr. Priv.-Doz. Dr. med. Stefan Landgraeber
- Hufelandstraße 55
- 45147 Essen
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0201/4089-2261
- 0201/4089-2722
- stefan.landgraeber at uni-due.de
- http://www.uniklinikum-essen.de
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- Two-year follow-up after advanced core decompression
- Advanced core decompression, a new treatment option of avascular necrosis of the femoral head – a first follow-up