AVNNCT04657653
Hyperbaric Oxygen Therapy Versus Core Decompression Augmented With Bone Substitute in Pre Collapse of Avascular Necrosis of Femoral Head
An observational study of AVN, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Introduction: osteonecrosis of the femoral head is a potentially crippling disorder, which mainly affects the young adults. Core decompression has been used for the treatment of the osteonecrosis of the femur head since was published by Ficat and albert, and by HUNGERFORD and Lennox. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AVN
- What is being tested?
- core decompression
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteQatar
- Study dates
- 13 Sep 2017to 31 Mar 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 19 patients with 23 pre-collapsed stage 2 non-traumatic AVN of femoral head were included, 12 (52.2%) in core CD and 11 (47.8%) in HBO group with average of 39.5±13 sessions. 9 (47.3%) males, 10 (52.7%) females, the average age was 35.2±9.8 years with average BMI 27.3±4.3 and follow up was 34.2±18.4 months. Risk factors was observed in 6 cases on steroid, 4 smokers, 1 DM, 3 sickle cell disease, 2 alcoholics, and 7 cases with no risk factors.
Who may be able to join
- 18 years old or more,
- non- traumatic AVN stages 2 (Steinberg)
- pre treatment MRI
- underwent either hyperbaric oxygen therapy or core decompression with bone substitute augmentation
- minimum one year of follow up were included
Who cannot join
- traumatic AVN,
- other stages of AVN (stages 1, 3, 4 and 5),
- core decompression without bone graft,
- combined therapy, other hip procedures
- less than one year follow up were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: osteonecrosis of the femoral head is a potentially crippling disorder, which mainly affects the young adults. Core decompression has been used for the treatment of the osteonecrosis of the femur head since was published by Ficat and albert, and by HUNGERFORD and Lennox. hyperbaric oxygen therapy is a suggestive joint preserving treatment for symptomatic prolapse stage of osteonecrosis of the femur head.
Aims and objectives: to compare the clinical (functional) outcome of core decompression versus hyperbaric oxygen therapy in pre collapse stages of idiopathic avascular necrosis of the femur head.
Read more
Material and methods: Mixed Retrospective and prospective study for all case of pre collapse of avascular necrosis of femoral head(AVNHF) underwent either hyperbaric oxygen therapy or Core decompression augmented with bone substitute in HAMAD General Hospital
Anticipated outcome: Hyperbaric oxygen treatment associated with better outcomes at preserving the joint and associated with less complications than surgery
Read the detailed description
Methods Data were collected retrospectively from the medical records from 23 patients, between January 2010 and December 2018. The data for patient's demographic (age, gender, body metabolic index (BMI) comorbidities, risk factors for avascular necrosis (AVN), (diabetes mellitus (DM), hypertension (HTN), alcoholic, smoking, steroid used, sickle cell disease, chemo or radiation therapy), pre- and post- treatment radiological stage (Steinberg's classification) [15],functional outcome (oxford hip score and SF 12), complications and need for further surgical intervention or Total Hip Arthroplasty (THA) were collected.
Patients who were 18 years old or more, with non- traumatic AVN in pre-collapse stage (stage 1 or 2 Steinberg)[15] that was confirmed by MRI and underwent either hyperbaric oxygen therapy or core decompression with bone substitute augmentation with a minimum one year of follow up were included.
Patient with traumatic AVN, advanced stages of AVN (stages 3, 4 and 5), core decompression without bone graft, combined therapy, other hip procedures and less than one year follow up were excluded from the study.
Writing Informed consent was obtained from all patients and they were interviewed through their regular clinical follow up with a minimum of 1-year follow up after the treatment. The clinical outcome was measured using Oxford hip score(OHS) and short form 12 (SF12) for both groups, the forms were used in two languages Arabic and English, the Arabic form was translated through the institutional medical research center by a certified translator.
Radiological progression of AVN stage was assessed by comparing radiographs before and after treatment. All radiographs and MRI images were reviewed and certified musculoskeletal radiologist did staging.
Satisfactory clinical outcome was defined as OHS score of more than 30 and no further surgical interventions. Radiological progression was identified with more advanced stages in post treatment radiographs.
Core Decompression surgical procedure:
Data analysis Descriptive statistics were used to summarize the patients' demographic, comorbidities and radiological measurements. Chi-square test and Fisher Exact test were used to express the associations between two or more qualitative variables whereas unpaired Student t test was used to compare the quantitative data (Oxford Hip Score \& SF12) between the two groups. Frequency (percentage) and mean ± standard deviation (SD) or median and range were used as appropriate for categorical and continuous values. The result was considered statistically significant if P value ≤.05. All statistical analyses were done using statistical packages SPSS 23.0 (SPSS Inc. Chicago, IL) and Epi information technology (InfoTM) 2000 (Centers for Disease Control and Prevention, Atlanta, GA)
- Conditions
- AVN
- Being tested
- core decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core decompressionProcedure or surgery
Also called hyperbaric oxygen therapy
:The procedure was performed under general anesthesia with the aid of image intensifier. All patients were positioned in supine position on a fracture table. The core decompression was performed using the direct lateral approach with 2 cm skin incision. A fluoroscope guided large single drill with 8 mm diameter over a guide wire was used to remove the necrotic tissues from the femur head through the lateral cortex distal to trochanteric tubercle. After the removal of the core necrotic bone, the track was filled with 5 ml synthetic bone paste substitute (tricalcium phosphate) and an intraoperative fluoroscope was used to confirm the adequacy of the decompression and grafting.
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the functional and radiological outcomes of the hyperbaric oxygen therapy (HBO) versus core decompression (CD) in pre-collapsed stage II of non-traumatic AVN of the femoral head.
comparing the oxford hip score and short form 12 score between patient who underwent core decompression and patients who underwent hyperbaric oxygen therapy and the progression of the disease through radiological evaluation
Measured: between January 2010 and December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start13 Sep 2017
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AVNStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Isam Moghamis, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657653
- Sponsor's protocol ID
- MRC/140/2017
- Status last verified
- Dec 2020
- First submitted
- 25 Nov 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy Versus Core Decompression Augmented With Bone Substitute in Pre Collapse of Avascular Necrosis of Femoral Head
- ClinicalTrials.gov ID
- NCT04657653
- Acronym / sponsor ID
- MRC/140/2017
- Conditions
- AVN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 8 Dec 2020 (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.
Introduction: osteonecrosis of the femoral head is a potentially crippling disorder, which mainly affects the young adults. Core decompression has been used for the treatment of the osteonecrosis of the femur head since was published by Ficat and albert, and by HUNGERFORD and Lennox. hyperbaric oxygen therapy is a suggestive joint preserving treatment for symptomatic prolapse stage of osteonecrosis of the femur head.
Aims and objectives: to compare the clinical (functional) outcome of core decompression versus hyperbaric oxygen therapy in pre collapse stages of idiopathic avascular necrosis of the femur head.
Material and methods: Mixed Retrospective and prospective study for all case of pre collapse of avascular necrosis of femoral head(AVNHF) underwent either hyperbaric oxygen therapy or Core decompression augmented with bone substitute in HAMAD General Hospital
Anticipated outcome: Hyperbaric oxygen treatment associated with better outcomes at preserving the joint and associated with less complications than surgery
Detailed description
Methods Data were collected retrospectively from the medical records from 23 patients, between January 2010 and December 2018. The data for patient's demographic (age, gender, body metabolic index (BMI) comorbidities, risk factors for avascular necrosis (AVN), (diabetes mellitus (DM), hypertension (HTN), alcoholic, smoking, steroid used, sickle cell disease, chemo or radiation therapy), pre- and post- treatment radiological stage (Steinberg's classification) [15],functional outcome (oxford hip score and SF 12), complications and need for further surgical intervention or Total Hip Arthroplasty (THA) were collected.
Patients who were 18 years old or more, with non- traumatic AVN in pre-collapse stage (stage 1 or 2 Steinberg)[15] that was confirmed by MRI and underwent either hyperbaric oxygen therapy or core decompression with bone substitute augmentation with a minimum one year of follow up were included.
Patient with traumatic AVN, advanced stages of AVN (stages 3, 4 and 5), core decompression without bone graft, combined therapy, other hip procedures and less than one year follow up were excluded from the study.
Writing Informed consent was obtained from all patients and they were interviewed through their regular clinical follow up with a minimum of 1-year follow up after the treatment. The clinical outcome was measured using Oxford hip score(OHS) and short form 12 (SF12) for both groups, the forms were used in two languages Arabic and English, the Arabic form was translated through the institutional medical research center by a certified translator.
Radiological progression of AVN stage was assessed by comparing radiographs before and after treatment. All radiographs and MRI images were reviewed and certified musculoskeletal radiologist did staging.
Satisfactory clinical outcome was defined as OHS score of more than 30 and no further surgical interventions. Radiological progression was identified with more advanced stages in post treatment radiographs.
Core Decompression surgical procedure:
Data analysis Descriptive statistics were used to summarize the patients' demographic, comorbidities and radiological measurements. Chi-square test and Fisher Exact test were used to express the associations between two or more qualitative variables whereas unpaired Student t test was used to compare the quantitative data (Oxford Hip Score \& SF12) between the two groups. Frequency (percentage) and mean ± standard deviation (SD) or median and range were used as appropriate for categorical and continuous values. The result was considered statistically significant if P value ≤.05. All statistical analyses were done using statistical packages SPSS 23.0 (SPSS Inc. Chicago, IL) and Epi information technology (InfoTM) 2000 (Centers for Disease Control and Prevention, Atlanta, GA)
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 19 patients with 23 pre-collapsed stage 2 non-traumatic AVN of femoral head were included, 12 (52.2%) in core CD and 11 (47.8%) in HBO group with average of 39.5±13 sessions. 9 (47.3%) males, 10 (52.7%) females, the average age was 35.2±9.8 years with average BMI 27.3±4.3 and follow up was 34.2±18.4 months. Risk factors was observed in 6 cases on steroid, 4 smokers, 1 DM, 3 sickle cell disease, 2 alcoholics, and 7 cases with no risk factors.
Key inclusion criteria (5 listed)
- 18 years old or more,
- non- traumatic AVN stages 2 (Steinberg)
- pre treatment MRI
- underwent either hyperbaric oxygen therapy or core decompression with bone substitute augmentation
- minimum one year of follow up were included
Key exclusion criteria (5 listed)
- traumatic AVN,
- other stages of AVN (stages 1, 3, 4 and 5),
- core decompression without bone graft,
- combined therapy, other hip procedures
- less than one year follow up were excluded from the study.
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 decompressionAlso: hyperbaric oxygen therapy:The procedure was performed under general anesthesia with the aid of image intensifier. All patients were positioned in supine position on a fracture table. The core decompression was performed using the direct lateral approach with 2 cm skin incision. A fluoroscope guided large single drill with 8 mm diameter over a guide wire was used to remove the necrotic tissues from the femur head through the lateral cortex distal to trochanteric tubercle. After the removal of the core necrotic bone, the track was filled with 5 ml synthetic bone paste substitute (tricalcium phosphate) and an intraoperative fluoroscope was used to confirm the adequacy of the decompression and grafting. | Procedure or surgery | – |
Primary outcome
compare the functional and radiological outcomes of the hyperbaric oxygen therapy (HBO) versus core decompression (CD) in pre-collapsed stage II of non-traumatic AVN of the femoral head.
Time frame: between January 2010 and December 2018
comparing the oxford hip score and short form 12 score between patient who underwent core decompression and patients who underwent hyperbaric oxygen therapy and the progression of the disease through radiological evaluation
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 10 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for AVN
Recruiting
Autologous Bone Marrow Aspirate Treatment for Early-Stage Osteonecrosis
Osteonecrosis of the Femoral Head, Avascular Necrosis of the Femoral Head
Not yet recruiting
Effect of HBOT on Femoral Head Avascular Necrosis (AVN)
Osteonecrosis, Avascular Necrosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AVN, run by Hamad Medical Corporation at 1 site in Qatar.
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 5 inclusion and 5 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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.
What does the primary outcome measure?
compare the functional and radiological outcomes of the hyperbaric oxygen therapy (HBO) versus core decompression (CD) in pre-collapsed stage II of non-traumatic AVN of the femoral head. (time frame: between January 2010 and December 2018). 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 10 Dec 2020.