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Hyperbaric Oxygen Therapy in Femoral Head …

Hyperbaric Oxygen Therapy in FemoralHead NecrosisEnrico M. Camporesi, MD,* Giuliano Vezzani, MD,yGerardo Bosco, MD, PhD,zDevanand Mangar, MD, and Thomas L. Bernasek, MD Abstract:We evaluated Hyperbaric Oxygen (HBO) Therapy on a cohort of patients with femoralhead necrosis (FHN). This double-blind, randomized, controlled, prospective study included20 patients with unilateral FHN. All were Ficat stage II, treated with either compressed Oxygen (HBO) or compressed air (HBA). Each patient received 30 treatments of HBO or HBA for 6 of motion, stabilometry, and pain were assessed at the beginning of the study and after 10,20, and 30 treatments by a blinded physician. After the initial 6-week treatment, the blind wasbroken; and all HBA patients were offered HBOtreatment. At this point, the study becomesobservational. Pretreatment, 12-month.

Hyperbaric Oxygen Therapy in Femoral Head Necrosis Enrico M. Camporesi, MD,* Giuliano Vezzani, MD,y Gerardo Bosco, MD, PhD,z …

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Transcription of Hyperbaric Oxygen Therapy in Femoral Head …

1 Hyperbaric Oxygen Therapy in FemoralHead NecrosisEnrico M. Camporesi, MD,* Giuliano Vezzani, MD,yGerardo Bosco, MD, PhD,zDevanand Mangar, MD, and Thomas L. Bernasek, MD Abstract:We evaluated Hyperbaric Oxygen (HBO) Therapy on a cohort of patients with femoralhead necrosis (FHN). This double-blind, randomized, controlled, prospective study included20 patients with unilateral FHN. All were Ficat stage II, treated with either compressed Oxygen (HBO) or compressed air (HBA). Each patient received 30 treatments of HBO or HBA for 6 of motion, stabilometry, and pain were assessed at the beginning of the study and after 10,20, and 30 treatments by a blinded physician. After the initial 6-week treatment, the blind wasbroken; and all HBA patients were offered HBOtreatment. At this point, the study becomesobservational. Pretreatment, 12-month.

2 And 7 year-follow-up magnetic resonance images wereobtained. Statistical comparisons were obtained with nonparametric pain improvement for HBO was demonstrated after 20 treatments. Range of motionimproved significantly during HBO for all parameters between 20 and 30 treatments. All patientsremain substantially pain-free 7 years later:none required hip arthroplasty. Substantialradiographic healing of the osteonecrosis was observed in 7 of 9 hips. Hyperbaric Oxygen therapyappears to be a viable treatment modality in patients with Ficat II :hyperbaricoxygen Therapy , Femoral head necrosis , hip arthroplasty. 2010 Published by Elsevier head necrosis (FHN) affects approximately10 000 to 15 000 patients in the United States annually[1]. The incidence has increased, possibly because of anincrease in the use of exogenous steroids, as well asincreases in the incidence of trauma and alcohol 3% of hip pathology is attributed toFHN.

3 Frequently, this starts between the fifth and sixthdecade of life with a male tofemale prevalence of 3 average age of affected patients is 47 years[2].Thissyndrome predominantly affects whites as comparedwith African Americans with a ratio of 3:1 and isusually is important to observe that there are 26 studies[3,4]where a declining clinical outcome after total hiparthroplastyinyoungerpatientsascompar edwitholder patients has been reported. This apparentdiscrepancy is not totally understandable; perhaps arole is played by the larger physical activity of youngerpatients and the possibility of an expected increase ofbody weight. For these reasons, there is a stream ofthinking among orthopedic surgeons that it would behelpful to delay or possibly not perform hip prosthesisespecially in the younger population[5-7].Amongalltherapies that may delay the requirement for hiparthroplasty, we believe Hyperbaric Oxygen Therapy (HBOT) may show a beneficial effect without theinvasiveness of this study, we are demonstrating an effectivetreatment modality that involves the use of HBOTto treat patients with FHN.

4 In these patients, wedescribe an overall symptomatic alleviation after amultiple-year follow-up, without necessitating hiparthroplasty is a double-blind, randomized, controlled, pro-spective study involving 20 patients (12 men and8 women) older than 18 years with idiopathic, unilateralFHN. Informed consent was obtained from all patientsbefore the start of the study. Every patient was subjectedto an x-ray of the hip in 2 projections (anterior andlateral), after diagnosis was confirmed by magneticresonance imaging (MRI), to stage their pathologyaccording to the Ficat classification. Only patients withoutFrom the *University of South Florida, Tampa, Florida;yOspedale di Vaio(Parma), Italy;zDepartment of Physiology, University G. D'Annunzio, Chieti,Italy; FGTB Anesthesia Associates, Tampa, Florida; and Florida OrthopedicInstitute, Tampa, January 25, 2010; accepted May 17, benefits or funds were received in support of the requests: Enrico M Camporesi, MD, University of SouthFlorida, 459 Severn Ave, Tampa, FL 33606.

5 2010 Published by Elsevier $ Journal of Arthroplasty Vol. 25 No. 6 Suppl. 1 2010any other underlying pathology, those receiving nopharmacologic treatment, and those diagnosed as Ficatstage II were included in this study. Patients with a historyof alcohol abuse, trauma to the involved hip, or steroiduse were excluded. At the initial presentation, eachpatient was randomly assigned to either arm of the physician overseeing their daily treatments wasaware of their random assignments; however, thephysician evaluating their progress after 10, 20, and30 treatments was blinded to their were prospectively randomized to either theHBO or Hyperbaric air (HBA) group. There were10 patients in the HBO group (6 men and 4 women)and 10 patients (6 men and 4 women) in the HBA group;however, one female patient assigned to the HBA groupdropped out after the first few treatments for personalreasons and was excluded from the study.

6 Therefore, thestudy group was completed with 10 HBO and 9 HBApatients. Both groups were simultaneously were exposed to HBO inside a multiplacehyperbaric chamber (Galeazzi, Bergamo, Italy) witheither compressed Oxygen or compressed air at ATAfor 82 minutes, comprising a period of 60 minutes whenthe patient was continuously exposed to ATA withoutinterruption. Each patient was provided with a well-sealed breathing mask from which he or she receivedeither 100% Oxygen (HBO) or 100% compressed air(HBA). Oxygen concentration in the mask was measuredevery 5 minutes to ensure adequacy of the gas supply andthe ability of providing a tight seal around the face. Themask was applied at the beginning of the session and waskept in place throughout the 82-minute treatmentsession without patients received 30 treatments of HBO or HBA fromMonday through Friday for a period of 6 weeks.

7 Aftercompletion of the first 6 weeks, the blind was broken; andall HBA patients were offered 6 weeks of HBO Therapy (crossover), which they accepted. At this point, the studybecomes an observational study. Furthermore, during therest of this first year, all 19 patients continued additionalHBO exposures as indicated by residual pain , these patients received 90 HBO treatments in 12months and underwent an MRI at the 12-month follow-up. After 7 years, a second follow-up was completed;however, 2 patients were lost to follow-up. Only 9 ofthese 17 patients had the original pretreatment MRI and12-month follow-up MRI in their possession. All9 patients underwent a 7-year follow-up MRI andtelephone both groups, hip flexion, extension, abduction,adduction, stabilometry, and intensity of pain wereassessed at the beginning of the study (T0), after10 treatments (T10), after 20 treatments (T20), andafter30treatments(T30) by a team physician blinded totheir treatment regimen.

8 Range of motion measure-mentsweremadeusingagoniometeronl yontheinvolved hip and were not compared with theuninvolved side. Stabilometry was measured using theplatform BASYS 95-SANITAS ELETTRIC MILANO. Inthis measurement, the load exerted on each leg (inpercentages) is measured independently while stand-ing. This is a more objective and reproducible mea-surement for load distribution between the right andleft leg[8]. We used this test to compare the weightdistribution between the right and left side during theinitial 30 treatments of both severity of pain in both groups was adequatelyassessed before the start of the study and after 10, 20,and 30 treatment sessions. Pain was assessed usingthevisualanaloguescorescale:a0to10s calewasused, with 0 representing no pain and 10 bearing after completion of the first 12 monthsof comparisons were executed using nonpara-metric Mann-WhitneyUtest to compare HBO vs HBAgroup because nearly all measured values were notnormally distributed (normality was checked usingKolmogorov-Smirnov test).

9 Statistical significance wasaccepted In addition, was adjustedfor multiple comparisons using a Bonferroni new level of , indicating that despite thesmall sample size, the probability of a type I errorwas Distribution of Patients Who Completed severity of pain scale in both Oxygen Therapy in Femoral Head necrosis Camporesi et al119 ResultsBoth groups of patients were similar in their demo-graphics;Table 1shows the mean age distribution,median, and range of both groups. The treatments werewell tolerated by both groups. There were no cerebralcomplications, otalgia, or other complications from theeffects of compression or Oxygen 1demonstrates the severity of pain on a 0 to10 scale in both groups. Although no statistical signifi-cance between both groups was noted at the beginningand following 10 sessions (P=.)

10 803), the HBO groupshowed marked improvement and significance after20 treatment sessions (P= .002 vs HBA) and after30 sessions ( ).Table 2represents the median values (in degrees) forthe range of motion in flexion, extension, adduction,and abduction for both groups. Although the results forflexion showed marked improvement (nearly doublingafter 30 treatments), the statistical analysis failed toshow any statistical significance at 10 (P= .335), 20 (P=.356), and 30 (P= .195) treatment sessions. Statisticalsignificance was achieved during extension, adduction,and abduction starting only after 10 sessions ( )and remained significant at 20 ( ) and30 treatment sessions ( ) when comparing theHBO and HBA 3represents stabilometry measurement in bothgroups before and after 10, 20, and 30 treatment the following table, the values for stabilometrycorrelate to the median value difference between theload on the unaffected limb and the load on the affectedlimb.


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