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临床试验/NCT04657653
NCT04657653已完成不适用

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

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
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.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

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.

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Isam Moghamis

medical resident

Hamad Medical Corporation

研究点 (1)

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