OsteonecrosisNCT04103944
A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
A study testing Core Decompression and Osteonecrotic Repair Device in people with Osteonecrosis, run by National Taiwan University Hospital.
Trial summary
Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Osteonecrosis
- What is being tested?
- Core Decompression and Osteonecrotic Repair Device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to Dec 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan
- Patients without any allergies or major systemic or organ diseases
- Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI
Who cannot join
- Other lower lib fractures
- Pregnancy
- Extensive degenerative arthritis in hip
- Severe osteoporosis in the head and/or neck of the femoral bone
- Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip
- Stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion
- Diagnosed with either Stage 4, 5, or 6, of ONFH classification by either radiography, MR, CT scan.
About this study
Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.
Read the detailed description
Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.
- Conditions
- Osteonecrosis
- Being tested
- Core Decompression, Osteonecrotic Repair Device
- Keywords
- osteonecrosis, osteonecrotic repair device
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core DecompressionProcedure or surgery
10 patients will be randomized chosen in this group
Osteonecrotic Repair DeviceProcedure or surgery
10 patients will be randomized chosen in this group
| Study group | Role | What they receive |
|---|---|---|
| Osteonecrotic Repair Device | Experimental | A biphasic osteochrondral composite method to support the regeneration of articular cartilage in vivo. With its concept that could be securely installed by press-fit without additional fixation, this approach can present an alternative to perform graft harvest and implantation in a single surgery. Receives: Procedure: Osteonecrotic Repair Device |
| Core Decompression | Active comparator | Core decompression is a common surgical procedure that aims to improve vascular inflow by decreasing intraosseous pressure in the femoral head. It is performed that involves removing a cylindrical core of bone from the proximal femur. Receives: Procedure: Core Decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
Questionaire Scoring
Measured: Baseline before procedure/surgery up to follow up 2 years after
Visual Analogue Scale(VAS)
Subjective Pain Scoring
Measured: Baseline before procedure/surgery up to follow up 2 years after
Harris Hip Score (HHS)
Scoring
Measured: Baseline before procedure/surgery up to follow up 2 years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jun 2014
- Primary completion31 May 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Intervention model
- Parallel groups
- Model description
- Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103944
- Sponsor's protocol ID
- 201111037DIB
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
- ClinicalTrials.gov ID
- NCT04103944
- Acronym / sponsor ID
- 201111037DIB
- Conditions
- Osteonecrosis
- Keywords
- osteonecrosis, osteonecrotic repair device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.
Detailed description
Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
| Arm | Type | Receives |
|---|---|---|
| Osteonecrotic Repair Device | Experimental | Procedure: Osteonecrotic Repair DeviceA biphasic osteochrondral composite method to support the regeneration of articular cartilage in vivo. With its concept that could be securely installed by press-fit without additional fixation, this approach can present an alternative to perform graft harvest and implantation in a single surgery. |
| Core Decompression | Active comparator | Procedure: Core DecompressionCore decompression is a common surgical procedure that aims to improve vascular inflow by decreasing intraosseous pressure in the femoral head. It is performed that involves removing a cylindrical core of bone from the proximal femur. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan
- Patients without any allergies or major systemic or organ diseases
- Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI
Key exclusion criteria (7 listed)
- Other lower lib fractures
- Pregnancy
- Extensive degenerative arthritis in hip
- Severe osteoporosis in the head and/or neck of the femoral bone
- Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip
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 Decompression10 patients will be randomized chosen in this group | Procedure or surgery | Core Decompression |
| Osteonecrotic Repair Device10 patients will be randomized chosen in this group | Procedure or surgery | Osteonecrotic Repair Device |
Primary outcome
Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
Time frame: Baseline before procedure/surgery up to follow up 2 years after
Questionaire Scoring
Visual Analogue Scale(VAS)
Time frame: Baseline before procedure/surgery up to follow up 2 years after
Subjective Pain Scoring
Harris Hip Score (HHS)
Time frame: Baseline before procedure/surgery up to follow up 2 years after
Scoring
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 26 Sep 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Core Decompression and Osteonecrotic Repair Device in people with Osteonecrosis, run by National Taiwan University Hospital.
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 7 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 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC) (time frame: Baseline before procedure/surgery up to follow up 2 years after). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 26 Sep 2019.