Hyperbaric Oxygen Therapy Versus Core Decompression Augmented With Bone Substitute in Pre Collapse of Avascular Necrosis of Femoral Head

AVN Clinical Trial

Official title:

Hyperbaric Oxygen Therapy Versus Core Decompression Augmented With Bone Substitute in Pre Collapse of Avascular Necrosis of Femoral Head

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04657653
• Other study ID #: MRC/140/2017
• Status: Completed
• Start date: September 13, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2020
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• AVN
• Necrosis

Intervention

Procedure:
• core decompression
: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.

Locations

Country	Name	City	State
Qatar	HamadMC	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	between January 2010 and December 2018