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result(s) for
"Necrosis - surgery"
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No Benefit After THA Performed With Computer-assisted Cup Placement: 10-year Results of a Randomized Controlled Study
by
Parratte, Sebastien
,
Flecher, Xavier
,
Lunebourg, Alexandre
in
Acetabulum - physiopathology
,
Acetabulum - surgery
,
Adult
2016
Background
Computer-assisted surgery (CAS) for cup placement has been developed to improve the functional results and to reduce the dislocation rate and wear after total hip arthroplasty (THA). Previously published studies demonstrated radiographic benefits of CAS in terms of implant position, but whether these improvements result in clinically important differences that patients might perceive remains largely unknown.
Questions/purposes
We hypothesized that THA performed with CAS would improve 10-year patient-reported outcomes measured by validated scoring tools, reduce acetabular polyethylene wear as measured using a validated radiological method, and increase survivorship.
Methods
Sixty patients operated on for a THA between April 2004 and April 2005 were randomized into two groups using either the CAS technique or a conventional technique for cup placement. All patient candidates for a THA with the diagnosis of primary arthritis or avascular necrosis were eligible for the CAS procedure and randomly assigned to the CAS group by the Hospital Informatics Department with use of a systematic sampling method. The patients assigned to the freehand cup placement group were matched for sex, age within 5 years, pathological condition, operatively treated side, and body mass index within 3 points. All patients were operated on through an anterolateral approach (patient in the supine position) using cementless implants. In the CAS group, a specific surgical procedure using an imageless cup positioning computer-based navigation system was performed. There were 16 men and 14 women in each group; mean age was 62 years (range, 24–80 years), and mean body mass index was 25 ± 3 kg/m
2
. No patient was lost to followup at 10 years, but five patients have died (two in the CAS group and three in the control group). At the 10-year followup, an independent observer blinded to the type of technique performed patients’ evaluation. Cup positioning was evaluated postoperatively using a CT scan in the two groups with results previously published. At 10 years, we assessed subjective functional outcome and quality of life using validated questionnaires (SF-12, Harris hip score [HHS], Hip injury and Osteoarthritis Outcome Score). Wear rate was then evaluated on standardized radiographs using a previously validated semiautomated computer analogic measurement method (dual circle method). Complications and survivorship were compared between groups. With our available sample size, this study had 80% power to detect a difference of 4 points out of 100 on the HHS at the p < 0.05 level.
Results
With the numbers available, we found we found no differences between groups regarding HSS at last followup 95.3 ± 5.9 points (CAS group) versus 96.2 ± 4.5 points, a mean difference of 0.9 points (95% confidence interval [CI], −4.3 to 4.6; p = 0.6). There was no difference between the groups in terms of the mean (± SD) acetabular linear wear at 10 years. The mean wear was 0.71 ± 0.6 mm in the CAS group versus 0.77 ± 0.52 mm in the control group, a mean difference of 0.06 mm (95% CI, −0.1 to 0.2; p = 0.54). With the numbers available, there was no difference between the CAS group and the conventional THA groups in terms of survivorship free from aseptic loosening (100%; 95% CI, 100%–95%, versus 100%; 95% CI, 100%–94%; p = 0.3).
Conclusions
Our observations suggest that CAS used for cup placement does not confer any substantial advantage in function, wear rate, or survivorship at 10 years after THA. Because CAS is associated with added costs and surgical time, future studies need to identify what clinically relevant advantages it offers, if any, to justify its continued use in THA.
Level of Evidence
Level II, therapeutic study.
Journal Article
Free Vascularized Fibular Grafting Improves Vascularity Compared With Core Decompression in Femoral Head Osteonecrosis: A Randomized Clinical Trial
2017
Background
Management of osteonecrosis of the femoral head remains challenging. Core decompression and free vascularized fibular grafting are commonly used surgical procedures for treatment of osteonecrosis of the femoral head. Few studies, however, have compared these two procedures in a randomized controlled study, in terms of improved vascularity of the femoral head, progression of disease, or hip scores.
Question/purposes
(1) What is the effect of core decompression and fibular grafting on vascularity of the femoral head as measured by single-photon emission CT (SPECT)/CT? (2) Does one of these two methods lead to greater progression of Association Research Circulation Osseous (ARCO) stage as determined by serial MRI? (3) What is the relationship between the change in vascularity of the femoral head and hip function as measured by the Harris hip score (HHS) and progression to THA as an endpoint?
Methods
A randomized controlled trial was performed between June 2010 and October 2012 at Zhongshan Hospital, Fudan University. During the study period, 51 patients who presented with ARCO Stages I to IIIB bilateral osteonecrosis were potentially eligible for inclusion, and 33 patients were identified as meeting the inclusion criteria and offered enrollment and randomization. Six patients declined to participate at the time of randomization, leaving a final sample of 27 participants (54 hips). Bilateral hips of each patient were randomly assigned to surgical options: one side was treated with core decompression and the contralateral side was concurrently treated with fibular grafting. SPECT/CT examinations were performed to quantify radionuclide uptake to evaluate vascularity of the femoral head before treatment and at 6 and 36 months after surgery. With the numbers available, we found no differences between the groups regarding vascularity at baseline (64% ± 8% core decompression-treated hips versus 64% ± 7% in the fibular-grafted hips; 95% CI, −5% to 5%; p = 0.90). MR images of the hips were obtained before surgery and at 6, 12, 24, and 36 months postoperatively and staged based on the ARCO classification. All patients were assessed clinically before treatment and followed up at 6, 12, 18, 24, 30, and 36 months after treatment using the HHS. We considered a difference in the HHS of 10 as the minimal clinically important difference (MCID). Patient progression to THA was defined as the endpoint for followup. Six patients (22%) were lost to followup.
Results
By SPECT/CT analysis, decompression-treated hips had lower vascularity than fibular-grafted hips at 6 months (68 % ± 6% versus 95% ± 5%; mean difference, −27%; 95% CI, −32% to −23%; p < 0.001) and 36 months (57% ± 4% versus 91% ± 3%; mean difference, −34%; 95% CI, −37% to −32%; p < 0.001). MRI analysis showed no differences between decompression-treated hips and fibular-grafted hips regarding ARCO stage at 12 months (p = 0.306) and 24 months (p = 0.06). Progression of ARCO staging was more severe in the decompression group than the fibular grafting group at 36 months (p = 0.027). The mean HHS was lower in the decompression group than in the fibular grafting group throughout the followup period, although these differences were at or below the MCID of 10 points early on. However, by 18 months, the scores favored fibular grafting (72 ± 4 versus 84 ± 4; mean difference, −13; 95% CI, −15 to −7; p < 0.001), a finding that was maintained at 24, 30, and 36 months. We found no differences between decompression-treated hips and fibular-grafted hips regarding progression to THA at 36 months (two of 21; p = 0.893).
Conclusions
Hips that underwent a vascularized fibular grafting procedure fared better than hips receiving core decompression as measured by improved vascularity and less progression of osteonecrosis as measured by ARCO staging. The mean HHS of the fibular-grafted hips was better than that of the decompression-treated hips during the entire postoperative period, but the differences were modest early on, and for the early postoperative period the differences were unlikely to have been clinically important; by 18 months after surgery, the differences probably were clinically important. The mid-term outcomes associated with vascularized fibular grafting seen in our patients are associated with improvements in femoral head vascularity and the potential for bone revitalization.
Level of Evidence
Level I, therapeutic study.
Journal Article
Transluminal endoscopic necrosectomy after acute pancreatitis: a multicentre study with long-term follow-up (the GEPARD Study)
2009
Background:As with endoscopic transmural drainage of peripancreatic fluid collections, the same transluminal access can be expanded to introduce an endoscope through the gastrointestinal wall into the retroperitoneum and remove infected pancreatic necroses under direct visual control. This study reports the first large series with long-term follow-up.Methods:Data for all patients undergoing transluminal endoscopic removal of (peri)pancreatic necroses between 1999 and 2005 in six different centres were collected retrospectively, and the patients were followed up prospectively until 2008. The initial patient and treatment outcome data were recorded, as were long-term results.Results:Ninety-three patients (63 men, 30 women; mean age 57 years) underwent a mean of six interventions starting at a mean of 43 days after an attack of severe acute pancreatitis. After establishment of transluminal access to the necrotic cavity and subsequent endoscopic necrosectomy, initial clinical success was obtained in 80% of the patients, with a 26% complication and a 7.5% mortality rate at 30 days. After a mean follow-up period of 43 months, 84% of the initially successfully treated patients had sustained clinical improvement, with 10% receiving further endoscopic and 4% receiving surgical treatment for recurrent cavities; 16% suffered recurrent pancreatitis.Conclusions:Direct transluminal endoscopic removal of pancreatic necroses is associated with good long-term maintenance of the high initial efficacy; complications can occur, with an associated mortality of around 7.5%. Further studies are necessary in order to optimise endotherapy and define its role in relation to surgery in the clinical management of such patients.
Journal Article
Supercapsular percutaneously-assisted total hip (SuperPath) versus posterolateral total hip arthroplasty in bilateral osteonecrosis of the femoral head: a pilot clinical trial
2019
Background
The supercapsular percutaneously-assisted total hip arthroplasty (SuperPath) was proposed to be minimally invasive and tissue sparing with possible superior postoperative outcomes to traditional approaches of total hip arthroplasty (THA). Here, we compared the short-term outcomes of staged THA with the SuperPath or through posterolateral approach (PLA) for bilateral osteonecrosis of the femoral head (ONFH).
Methods
Patients with bilateral late-stage ONFH were prospectively recruited from our department from March 2017 to March 2018. Staged bilateral THAs with one side SuperPath and the other side PLA were performed consecutively in the same patients with right and left hips alternating within approaches. The average time interval between the staged THAs was 3 months. Perioperative status (operation time, incision length, intraoperative blood loss, soft tissue damage, and length of hospital stay) and postoperative function (range of motion, pain, and hip function) were recorded and compared between the SuperPath and PLA approaches within 12-month postoperatively.
Results
Four male patients (age, 51.00 ± 4.54; BMI, 21.49 ± 1.73) with bilateral alcohol-induced ONFH (Ficat III/IV) were followed up over 12 months postoperatively. Compared with the PLA, the SuperPath yielded shorter incision length (7.62 vs. 11.12 cm), longer operation time (103.25 vs. 66.50 min), more blood loss (1108.50 vs. 843.50 ml), deficient abduction angle of the acetabular cup (38.75° vs. 44.50°), and inferior early-term hip function (Harris hip score, 72.50 vs. 83.25) at 12-month postoperatively. Soft tissue damage, length of hospital stay, postoperative pain, postoperative range of motion, and 12-month patient satisfaction were comparable between both approaches.
Conclusion
The SuperPath may be a minimally invasive technique but the present study shows less favorable short-term outcomes than PLA for total hip arthroplasty in osteonecrosis of the femoral head. More investigations are required to provide convincing favorable evidences of the SuperPath over other traditional THA approaches.
Trial registration information
The trial was retrospectively registered in
https://www.researchregistry.com
(No. Researchregistry4993) on July 04, 2019. The first participant was enrolled on March 13, 2017.
Journal Article
Ultrashort versus Conventional Anatomic Cementless Femoral Stems in the Same Patients Younger Than 55 Years
by
Kim, Young-Hoo
,
Park, Jang-Won
,
Kim, Jun-Shik
in
Adult
,
Age Factors
,
Arthroplasty, Replacement, Hip - adverse effects
2016
Background
Because the clinical and radiographic performance of an ultrashort anatomic cementless stem has been investigated in only two randomized controlled studies, well-designed trials should aim for a thorough comparison of the outcomes of ultrashort anatomic cementless and conventional anatomic cementless stems.
Questions/purposes
The purposes of this study were to compare (1) the clinical results, including Harris hip score, thigh pain, and WOMAC index score, (2) radiographic results, (3) bone mineral density; and (4) proportions of patients undergoing revision of a THA using an ultrashort anatomic cementless stem versus a conventional anatomic cementless stem in the same patients who underwent bilateral sequential THAs under the same anesthetic.
Methods
Two hundred patients (mean age, 53 years; range, 26–54 years) who underwent bilateral sequential THAs received an ultrashort anatomic cementless stem in one hip and a conventional anatomic cementless stem in the contralateral hip. From January 2004 to December 2005, we performed 524 same-day bilateral short and conventional anatomic cementless THAs in 262 patients, of whom 212 (81%) participated in this study. Five patients were lost to followup before 2 years, five were lost between 2 to 10 years, and two were lost between 10 to 13 years, leaving 200 patients. Patients who had end-stage bilateral hip disease and were younger than 55 years were selected for inclusion. The predominant diagnoses were osteonecrosis (118 patients, 59%) and osteoarthritis (44 patients, 22%). One hundred thirty-eight were men and 62 were women. At the time of each followup, the patients were assessed clinically and radiographically. In addition, each patient completed the WOMAC and the University of California Los Angeles (UCLA) activity scores. The minimum followup was 10 years (mean, 11.8 years; range, 10–13 years). Followups were done in person, with all images and followup clinic notes. Based on the power analysis, we estimated a sample size of 178 hips was needed in each group to detect a 3-point difference in the Harris hip score with 80% power.
Results
At the latest followup, there were no differences between the two groups regarding the mean Harris hip scores (94 versus 94 points; p = 0.189), mean WOMAC scores (17 versus 16 points; p = 0.191), or mean UCLA activity scores (9 versus 9 points; p = 0.381). Two patients in the ultrashort stem group and one patient in the conventional stem group had severe (9 points) thigh pain, and 30 patients (15%) in the conventional stem group had mild thigh pain (2 or 3 points) after vigorous exercise. Bone mineral density in the ultrashort and conventional stem groups, respectively, was greater in the ultrashort stem group than in the conventional stem group. Bone mineral density in Zone 1 at 12 years was 3.29 versus 1.88 g/cm
2
(p = 0.021), and 2.97 versus 0.91 g/m
2
in Zone 7 (p = 0.001). With the numbers available, there were no differences between the stem designs in terms of the proportion undergoing revision (one hip, 0.5%, in the short-stem group versus one hip, 0.5%, in the conventional group; p = 1.881).
Conclusions
At followup into the second decade, ultrashort stems showed no differences from conventional cementless stems in terms of validated outcomes scores or fixation, although less stress shielding was observed. Reduction of stress shielding may reduce the long-term risk of periprosthetic fracture, but this was not shown in our study.
Level of Evidence
Level I, therapeutic study.
Journal Article
Efficacy of synovectomy in the treatment of femoral head osteonecrosis with vascularised fibular grafting in Shanghai: a protocol for SYNERGY-VGF trial
2025
BackgroundOsteonecrosis of the femoral head (ONFH) is characterised by progressive bone death, leading to joint incongruity and eventual osteoarthritis. Various interventions have been explored to forestall disease progression and delay total hip arthroplasty (THA). Free vascularised fibula grafting (FVFG) has shown promise, particularly in the precollapse stages of ONFH. However, the potential benefits of combining synovectomy with FVFG to address synovitis in ONFH have not been systematically studied. This trial seeks to compare outcomes between patients undergoing FVFG with and without synovectomy.Methods and analysisThe trial is a randomised, single-centre, parallel-group trial comparing FVFG with synovectomy versus FVFG alone in patients with ONFH and synovitis. 90 participants will be randomised into two groups: synovectomy (n=45) and non-synovectomy (n=45). The primary outcome is the Harris Hip Score (HHS) change at 12 months post surgery. Secondary outcomes include HHS, Numeric Rating Scale (NRS) for pain, Depression Anxiety Stress Scales-21 (DASS-21), and EQ-5D scale assessments at intervals up to 12 months post randomisation.Ethics and disseminationThis trial was approved by the Human Research Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine prior to patient recruitment (approval number: 2023-076). Results from this trial will be published in peer-reviewed journals. Results will also be presented at international conferences.Trial registration numberChinese Clinical Trial Registry (ChiCTR) Identifier: ChiCTR2300073385. Prospectively registered on 10 July 2023.
Journal Article
Long-Term Follow-up of 25 Cases of Biopsy-Proven Radiation Necrosis or Post-Radiation Treatment Effect Treated With Magnetic Resonance-Guided Laser Interstitial Thermal Therapy
2016
Abstract
BACKGROUND:
Magnetic resonance-guided laser-induced thermal therapy (MRgLITT) is a minimally invasive surgical treatment for progressive neoplasms and post-radiation treatment effect (PRTE).
OBJECTIVE:
To evaluate the radiographic response and efficacy of MRgLITT for biopsy-confirmed PRTE and the quality-of-life outcomes of patients following MRgLITT.
METHODS:
We conducted a single-center retrospective study of radiographic responses and clinical outcomes of 25 patients with previously treated primary or secondary brain neoplasms (World Health Organization grades 4 [n = 8], 3 [n = 5], 2 [n = 5]) and metastatic brain tumors (n = 7). MRgLITT was applied directly following stereotactic needle biopsy confirming PRTE without any evidence of tumor presence.
RESULTS:
Mean overall survival times (months) for grades 4 and 3 and for metastatic brain tumors were 39.2 (standard error [SE], 7.6; 95% confidence interval [CI], 24.3-54.1), 29.1 (SE, 7.7; 95% CI, 14.0-44.2), and 55.9 (SE, 10.0; 95% CI, 36.3-75.4), respectively. Mean progression-free survival times after MRgLITT were 9.1 (SE, 3.6; 95% CI, 2.1-16.1), 8.5 (SE, 2.4; 95% CI, 3.9-13.2), and 11.4 (SE, 3.9; 95% CI, 3.8-19.0), respectively. Mean survival times after MRgLITT were 13.1 (SE, 2.3; 95% CI, 8.5-17.6), 12.2 (SE, 4.0; 95% CI, 4.4-20.0), and 19.2 (SE, 5.3; 95% CI, 8.9-29.6), respectively. The SF-36 indicated significant overall effects on mental health (P = .029) and vitality (P = .005).
CONCLUSION:
MRgLITT may be a viable option for patients with symptomatic advancing PRTE and is less invasive than open craniotomy. Although our results suggest a positive effect for MRgLITT on PRTE, prospective randomized trials with larger numbers of patients are needed to validate the study results.
Journal Article
Evaluation of the effect of different irrigation solutions used in regenerative endodontic treatment of necrotic molar teeth with open apex on postoperative pain- randomized clinical trial
2025
Objectives
This study evaluates the effect of different irrigation solutions for postoperative pain in the regenerative endodontic treatments (RET) of necrotic teeth with open apex.
Materials and methods
This study included necrotic, deeply carious lower molars of 42 patients. Access cavities of the teeth were opened and working lengths were measured at the first visit. In Group 1, the root canals were irrigated with 1.5% sodium hypochlorite (NaOCl) and 17% Ethylenediaminetetraacetic-acid (EDTA), in Group 2, with 1.5% NaOCl and 10% citric acid, and in the Group 3, with 1.5% NaOCl and 9% Etidronic acid (HEDP) mixture solution. Final irrigation was performed with distilled water. The canals were dried, filled with calcium hydroxide paste, and sealed with Cavit. Postoperative pain was assessed using a numerical rating scale, and Paracetamol was prescribed. At the second visit, calcium hydroxide was removed with 1.5% NaOCl, irrigated with chelators, and sealed with Sure-Seal PT 3 mm below the cementoenamel junction before composite resin filling.
Results
Postoperative pain was higher in Group 3 (
p
< 0.05), but analgesic consumption did not show a significant difference (
p
> 0.05).
Conclusions
HEDP caused significantly more postoperative pain than EDTA and citric acid (
p
< 0.05). While the study provided information regarding the effects of irrigation solutions on postoperative pain, further research is needed as it did not include detailed assessments of long-term periapical healing and apex closure.
Clinical relevance
When HEDP is used as a chelation agent in RETs, it shows a higher degree of postoperative pain than EDTA and citric acid solutions.
Clinical trial registration
The study protocol was registered at
www.clinicaltrials.gov
(ID: NCT 06386991).
Journal Article
10-year follow-up results of the prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with avascular necrosis of the femoral head
2020
Background
Avascular necrosis of the femoral head (ANFH) is a severely disabling disease of the hip. Several clinical trials have shown promising outcomes on the use of mesenchymal stem cells for the treatment of ANFH, but long-term clinical assessments are lacking. Previously, we reported the 2-year follow-up results of a prospective, double-blinded, randomized, controlled study on autologous bone marrow buffy coat grafting combined with core decompression in patients with ANFH. Here, we report the 10-year follow-up results of this study.
Methods
We recruited 43 (53 hips) patients from 2009 to 2010. The hips were randomly allocated to code decompression (CD) with or without bone marrow buffy coat (BBC) grafting. Participants underwent follow-up at 24, 60, and 120 months postoperatively. The visual analogue scale (VAS), Lequesne algofunctional index, and Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis scores were recorded. Survival rate analysis and prognostic factor analysis were performed. The endpoint was defined as progression to Ficat stage IV or conversion to hip arthroplasty.
Results
A total of 31 patients (41 hips) were included in the final analysis. The CD + BBC group had better subjective assessment scores than the CD group. The average survival times were 102.3 months and 78.1 months in the CD + BBC group and CD group, respectively (log-rank test,
P
= 0.029). In the univariate Cox proportional hazards regression model, age [hazard ratio (HR) = 1.079,
P
= 0.047] and preoperative Ficat stage (HR = 3.283,
P
= 0.028) indicated a high risk for progression, while the use of BBC (HR = 0.332,
P
= 0.042) indicated a low risk. Preoperative Ficat stage III was isolated as an independent risk factor for clinical failure in the multivariate model (HR = 3.743,
P
= 0.018).
Conclusion
The 10-year follow-up results of this prospective, double-blinded, randomized, controlled study showed that the use of autologous BBC in combination with core decompression was more effective than the use of core decompression alone.
Trial registration
ClinicalTrials.gov,
NCT01613612
. Registered on 13 December 2011—retrospectively registered
Journal Article
Fat Necrosis After Autologous Fat Transfer (AFT) to Breast: Comparison of Low-Speed Centrifugation with Sedimentation
2018
BackgroundDespite the advantages of autologous fat transfer to the breast, there are many complications after the surgery, such as oil cysts, calcification and palpable breast nodules. The fat purification process is a key step to reduce those complications, but there is currently no standard processing method. This study was designed to compare the incidence of fat necrosis after autologous fat grafting to the breast with low-speed centrifugation and sedimentation.MethodsThis study analyzed 100 patients (167 breasts) who underwent autologous fat grafts to the breasts from January, 2015 to March, 2017. Patients were divided into two groups randomly, low-speed centrifugation (800 r/min) and sedimentation (15 min). Postoperative fat necrosis such as oil cysts and palpable breast nodules was measured using physical examination and breast ultrasound 3 months after the surgery. The number and the diameter of the fat necroses were detected.ResultsA total of 100 patients (167 breasts) were included this research. There were 21 breasts with clinically palpable nodules (12.57%); fifteen (19.48%) were in the low-speed centrifugation group and six (6.67%) were in the sedimentation group (p < 0.05). According to postoperative breast ultrasounds, there were 83 breasts with hypoechoic cyst formations (49.7%); forty-five (58.44%) in the low-speed centrifugation group and 38 (42.22%) in the sedimentation group (p < 0.05). A positive correlation between the number of operative sessions and fat necrosis was found out.ConclusionAlthough low-speed centrifugation could achieve higher fat purification efficacy when compared with sedimentation, it causes more fat necrosis than sedimentation, such as clinically palpable nodules and subclinical nodules, especially in patients who had a history of breast surgery and those who needed more than one fat grafting session.Level of Evidence IIIThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Journal Article