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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Qatar1 site
  • HamadMC

    Doha

Other trials in Qatar

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.

  1. 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.

  1. First posted8 Dec 2020
  2. Study start13 Sep 2017
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

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
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

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.

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