Plain English Summary
Background and study aims
Osteonecrosis is a disease caused by reduced blood flow to the bones in the joints. The bone starts to die and may break down. Osteonecrosis can affect the femoral head, which is the highest part of the thigh bone that “plugs into” the hip socket. Extracorporeal shockwave therapy (ESWT) is a procedure where a device passes sound waves through the skin to the affected bone, improving the blood flow. This study investigates the effects of different doses of ESWT on patients with early osteonecrosis of the femoral head (ONFH).
Who can participate?
Patients aged over 18 with ONFH
What does the study involve?
Participants are randomly allocated into three groups which receive different doses of ESWT. Participants are assessed with x-ray and MRI scans, and blood samples are taken.
What are the possible benefits and risks of participating?
ESWT may relieve pain and improve hip function.
Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
August 2011 to July 2015
Who is funding the study?
Chang Gung Medical Foundation (Taiwan)
Who is the main contact?
Dr Ching-Jen Wang
w281211@adm.cgmh.org.tw
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ching-Jen Wang
ORCID ID
Contact details
123
Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan
+886 (0)7 7335279
w281211@adm.cgmh.org.tw
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
98-2554A3
Study information
Scientific title
Extracorporeal shockwave technology in hip necrosis: a dosage validation and systemic concentrations of serum NO levels of angiogenesis and osteogenesis factors and other biomarkers
Acronym
Study hypothesis
The etiology of osteonecrosis of the femoral head (ONFH) is multi-factorial, and the treatment is disease stage dependent. Core decompression with or without bone grafting for symptomatic early stage ONFH, and total hip replacement for late stage of the disease are considered the gold standards. However, the results of core decompression are inconsistent and unpredictable despite of good results reported in selective series, and many patients eventually undergo hip replacement surgery. Therefore, an effective non-invasive method of treatment is imperative and attractive for patients with early ONFH.
This study investigated the systemic and local effects of different dosages of extracorporeal shockwave therapy (ESWT) in early osteonecrosis of the femoral head (ONFH).
Ethics approval
The Institutional Review Board of Chang Gung Memorial Hospital, 25/03/2010, IRB no: 98-2554A3
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteonecrosis of the femoral head
Intervention
The initial protocol intends to recruit 60 patients. Patients are randomly divided into three groups with 20 patients in group I who receive 2000 impulses of ESWT at 24 Kv; 20 patients in group II who receive 4000 impulses of ESWT at 24 Kv and 20 patients in group III who receive 6000 impulses of ESWT at 24 Kv.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. The number of total hip arthroplasty (THA) performed during the study period (1 year)
2. Pain (VAS) score and Harris hip score
3. Changes on X-ray and MRI studies
Secondary outcome measures
Ten milliliters of peripheral blood are obtained for measurements of serum NO level, VEGF and TGF-α; BMP-2, osteocalcin, DKK-1, IGF and IL-6 before treatment and at 1, 3, 6 and 12 months after treatment.
Overall trial start date
01/08/2011
Overall trial end date
31/07/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Over 18 years old
2. ONFH in stage I, stage II or stage III-a according to ARCO classification at initial presentation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patients with late stages of the disease (stages III-b, III-c or stage IV)
2. Patients under 18 years of age
3. Patients with cardiac arrhythmia or pacemaker
4. Patients on immunosuppressant drugs
5. Patients with infection or advanced arthritis
6. Patients with coagulopathy
7. Chronic renal failure
8. Pregnancy
9. Poor compliant patients
Recruitment start date
24/10/2011
Recruitment end date
24/07/2015
Locations
Countries of recruitment
Taiwan
Trial participating centre
Kaohsiung Chang Gung Memorial Hospital
123, Ta Pei Road
Niao Sung District
Kaohsiung
83305
Taiwan
Funders
Funder type
Hospital/treatment centre
Funder name
Chang Gung Medical Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Taiwan
Results and Publications
Publication and dissemination plan
To be confirmed at later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list