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

NCT04657653 | Completed

• 1 other identifier: MRC/140/2017
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

AVN

Outcome Measures

Primary Outcomes (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

  between January 2010 and December 2018

Interventions

core decompression PROCEDURE

: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.

Also known as: hyperbaric oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

HamadMC

Doha, Qatar

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical resident

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 8, 2020
• Study Start: September 13, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

QA (1)