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The Bone & Joint Journal
Vol. 99-B, Issue 5 | Pages 592 - 600
1 May 2017
Matharu GS Nandra RS Berryman F Judge A Pynsent PB Dunlop DJ

Aims. To determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure. Patients and Methods. We retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression. Results. Failure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007). Conclusion. We observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms. Cite this article: Bone Joint J 2017;99-B:592–600


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 33 - 41
1 Jan 2018
Matharu GS Hunt LP Murray DW Howard P Pandit HG Blom AW Bolland B Judge A

Aims. The aim of this study was to determine whether the rates of revision for metal-on-metal (MoM) total hip arthroplasties (THAs) with Pinnacle components varied according to the year of the initial operation, and compare these with the rates of revision for other designs of MoM THA. Patients and Methods. Data from the National Joint Registry for England and Wales included 36 mm MoM THAs with Pinnacle acetabular components which were undertaken between 2003 and 2012 with follow-up for at least five years (n = 10 776) and a control group of other MoM THAs (n = 13 817). The effect of the year of the primary operation on all-cause rates of revision was assessed using Cox regression and interrupted time-series analysis. Results. For MoM THAs involving Pinnacle components, those undertaken between 2007 and 2012 had higher rates of revision compared with those undertaken between 2004 and 2006 (hazard ratio (HR) 2.01; 95% confidence interval (CI) 1.57 to 2.57; p < 0.001). For THAs undertaken during and after 2007, the number of revisions per 1000 implant-years at risk significantly increased by 5.20 (95% CI 0.52 to 9.89; p = 0.033) compared with those undertaken before this time. In the control group, THAs undertaken between 2007 and 2012 also had higher rates of revision (HR 1.77; 95% CI 1.49 to 2.10; p < 0.001), with revisions per 1000 implant-years for those undertaken during and after 2007 significantly increasing by 6.13 (95% CI 1.42 to 10.83; p = 0.016). Conclusion. The five-year revision rates were significantly increased for all primary MoM THAs undertaken from 2007 onwards. Contrary to recent reports, this finding was not specific to those involving Pinnacle acetabular components and may be explained by increased surveillance and recent lowering of the threshold for revision. Cite this article: Bone Joint J 2018;100-B:33–41


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1589 - 1596
1 Dec 2016
Magill P Blaney J Hill JC Bonnin MP Beverland DE

Aims. Our aim was to report survivorship data and lessons learned with the Corail/Pinnacle cementless total hip arthroplasty (THA) system. Patients and Methods. Between August 2005 and March 2015, a total of 4802 primary cementless Corail/Pinnacle THAs were performed in 4309 patients. In March 2016, we reviewed these hips from a prospectively maintained database. Results . A total of 80 hips (1.67%) have been revised which is equivalent to a cumulative risk of revision of 2.5% at ten years. The rate of revision was not significantly higher in patients aged ≥ 70 years (p = 0.93). The leading indications for revision were instability (n = 22, 0.46%), infection (n = 20, 0.42%), aseptic femoral loosening (n = 15, 0.31%) and femoral fracture (n = 6, 0.12%). There were changes in the surgical technique with respect to the Corail femoral component during the ten-year period involving a change to collared components and a trend towards larger size. These resulted in a decrease in the rate of iatrogenic femoral fracture and a decrease in the rate of aseptic loosening. Conclusion. The rate of revision in this series is comparable with the best performing THAs in registry data. Most revisions were not directly related to the implants. Despite extensive previous experience with cemented femoral components, the senior author noted a learning curve requiring increased focus on primary stability. The number of revisions related to the femoral component is reducing. Any new technology has a learning curve that may be independent of surgical experience. Cite this article: Bone Joint J 2016;98-B:1589–96


The Bone & Joint Journal
Vol. 97-B, Issue 6 | Pages 762 - 770
1 Jun 2015
Pennington MW Grieve R van der Meulen JH

There is little evidence on the cost effectiveness of different brands of hip prostheses. We compared lifetime cost effectiveness of frequently used brands within types of prosthesis including cemented (Exeter V40 Contemporary, Exeter V40 Duration and Exeter V40 Elite Plus Ogee), cementless (Corail Pinnacle, Accolade Trident, and Taperloc Exceed) and hybrid (Exeter V40 Trilogy, Exeter V40 Trident, and CPT Trilogy). We used data from three linked English national databases to estimate the lifetime risk of revision, quality-adjusted life years (QALYs) and cost. . For women with osteoarthritis aged 70 years, the Exeter V40 Elite Plus Ogee had the lowest risk of revision (5.9% revision risk, 9.0 QALYs) and the CPT Trilogy had the highest QALYs (10.9% revision risk, 9.3 QALYs). Compared with the Corail Pinnacle (9.3% revision risk, 9.22 QALYs), the most commonly used brand, and assuming a willingness-to-pay of £20 000 per QALY gain, the CPT Trilogy is most cost effective, with an incremental net monetary benefit of £876. Differences in cost effectiveness between the hybrid CPT Trilogy and Exeter V40 Trident and the cementless Corail Pinnacle and Taperloc Exceed were small, and a cautious interpretation is required, given the limitations of the available information. However, it is unlikely that cemented brands are among the most cost effective. Similar patterns of results were observed for men and other ages. The gain in quality of life after total hip arthroplasty, rather than the risk of revision, was the main driver of cost effectiveness. Cite this article: Bone Joint J 2015;97-B:762–70


The Bone & Joint Journal
Vol. 96-B, Issue 12 | Pages 1610 - 1617
1 Dec 2014
Lainiala O Eskelinen A Elo P Puolakka T Korhonen J Moilanen T

We conducted a retrospective study to assess the prevalence of adverse reactions to metal debris (ARMD) in patients operated on at our institution with metal-on-metal (MoM) total hip replacements with 36 mm heads using a Pinnacle acetabular shell. A total of 326 patients (150 males, 175 hips; 176 females, 203 hips) with a mean age of 62.7 years (28 to 85) and mean follow-up of 7.5 years (0.1 to 10.8) participating in our in-depth modern MoM follow-up programme were included in the study, which involved recording whole blood cobalt and chromium ion measurements, Oxford hip scores (OHS) and plain radiographs of the hip and targeted cross-sectional imaging. Elevated blood metal ion levels (> 5 parts per billion) were seen in 32 (16.1%) of the 199 patients who underwent unilateral replacement. At 23 months after the start of our modern MoM follow-up programme, 29 new cases of ARMD had been revealed. Hence, the nine-year survival of this cohort declined from 96% (95% CI 95 to 98) with the old surveillance routine to 86% (95% CI 82 to 90) following the new protocol. Although ARMD may not be as common in 36 mm MoM THRs as in those with larger heads, these results support the Medicines and Healthcare Products Regulatory Agency guidelines on regular reviews and further investigations, and emphasise the need for specific a follow-up programme for patients with MoM THRs. Cite this article: Bone Joint J 2014; 96-B:1610–17


The Bone & Joint Journal
Vol. 95-B, Issue 6 | Pages 747 - 757
1 Jun 2013
Jameson SS Baker PN Mason J Rymaszewska M Gregg PJ Deehan DJ Reed MR

The popularity of cementless total hip replacement (THR) has surpassed cemented THR in England and Wales. This retrospective cohort study records survival time to revision following primary cementless THR with the most common combination (accounting for almost a third of all cementless THRs), and explores risk factors independently associated with failure, using data from the National Joint Registry for England and Wales. Patients with osteoarthritis who had a DePuy Corail/Pinnacle THR implanted between the establishment of the registry in 2003 and 31 December 2010 were included within analyses. There were 35 386 procedures. Cox proportional hazard models were used to analyse the extent to which the risk of revision was related to patient, surgeon and implant covariates. The overall rate of revision at five years was 2.4% (99% confidence interval 2.02 to 2.79). In the final adjusted model, we found that the risk of revision was significantly higher in patients receiving metal-on-metal (MoM: hazard ratio (HR) 1.93, p < 0.001) and ceramic-on-ceramic bearings (CoC: HR 1.55, p = 0.003) compared with the best performing bearing (metal-on-polyethylene). The risk of revision was also greater for smaller femoral stems (sizes 8 to 10: HR 1.82, p < 0.001) compared with mid-range sizes. In a secondary analysis of only patients where body mass index (BMI) data were available (n = 17 166), BMI ≥ 30 kg/m. 2. significantly increased the risk of revision (HR 1.55, p = 0.002). The influence of the bearing on the risk of revision remained significant (MoM: HR 2.19, p < 0.001; CoC: HR 2.09, p = 0.001). The risk of revision was independent of age, gender, head size and offset, shell, liner and stem type, and surgeon characteristics. We found significant differences in failure between bearing surfaces and femoral stem size after adjustment for a range of covariates in a large cohort of single-brand cementless THRs. In this study of procedures performed since 2003, hard bearings had significantly higher rates of revision, but we found no evidence that head size had an effect. Patient characteristics, such as BMI and American Society of Anesthesiologists grade, also influence the survival of cementless components. Cite this article: Bone Joint J 2013;95-B:747–57


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 555 - 564
1 Jun 2024
Leal J Holland CT Cochrane NH Seyler TM Jiranek WA Wellman SS Bolognesi MP Ryan SP

Aims

This study aims to assess the relationship between history of pseudotumour formation secondary to metal-on-metal (MoM) implants and periprosthetic joint infection (PJI) rate, as well as establish ESR and CRP thresholds that are suggestive of infection in these patients. We hypothesized that patients with a pseudotumour were at increased risk of infection.

Methods

A total of 1,171 total hip arthroplasty (THA) patients with MoM articulations from August 2000 to March 2014 were retrospectively identified. Of those, 328 patients underwent metal artefact reduction sequence MRI and had minimum two years’ clinical follow-up, and met our inclusion criteria. Data collected included demographic details, surgical indication, laterality, implants used, history of pseudotumour, and their corresponding preoperative ESR (mm/hr) and CRP (mg/dl) levels. Multivariate logistic regression modelling was used to evaluate PJI and history of pseudotumour, and receiver operating characteristic curves were created to assess the diagnostic capabilities of ESR and CRP to determine the presence of infection in patients undergoing revision surgery.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 768 - 774
1 Jul 2023
Wooster BM Kennedy NI Dugdale EM Sierra RJ Perry KI Berry DJ Abdel MP

Aims

Contemporary outcomes of primary total hip arthroplasties (THAs) with highly cross-linked polyethylene (HXLPE) liners in patients with inflammatory arthritis have not been well studied. This study examined the implant survivorship, complications, radiological results, and clinical outcomes of THA in patients with inflammatory arthritis.

Methods

We identified 418 hips (350 patients) with a primary diagnosis of inflammatory arthritis who underwent primary THA with HXLPE liners from January 2000 to December 2017. Of these hips, 68% had rheumatoid arthritis (n = 286), 13% ankylosing spondylitis (n = 53), 7% juvenile rheumatoid arthritis (n = 29), 6% psoriatic arthritis (n = 24), 5% systemic lupus erythematosus (n = 23), and 1% scleroderma (n = 3). Mean age was 58 years (SD 14.8), 66.3% were female (n = 277), and mean BMI was 29 kg/m2 (SD 7). Uncemented femoral components were used in 77% of cases (n = 320). Uncemented acetabular components were used in all patients. Competing risk analysis was used accounting for death. Mean follow-up was 4.5 years (2 to 18).


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 826 - 832
1 Jul 2022
Stadelmann VA Rüdiger HA Nauer S Leunig M

Aims

It is not known whether preservation of the capsule of the hip positively affects patient-reported outcome measures (PROMs) in total hip arthroplasty using the direct anterior approach (DAA-THA). A recent randomized controlled trial found no clinically significant difference at one year postoperatively. This study aimed to determine whether preservation of the anterolateral capsule and anatomical closure improve the outcome and revision rate, when compared with resection of the anterolateral capsule, at two years postoperatively.

Methods

Two consecutive groups of patients whose operations were performed by the senior author were compared. The anterolateral capsule was resected in the first group of 430 patients between January 2012 and December 2014, and preserved and anatomically closed in the second group of 450 patients between July 2015 and December 2017. There were no other technical changes between the two groups. Patient characteristics, the Charlson Comorbidity Index (CCI), and surgical data were collected from our database. PROM questionnaires, consisting of the Oxford Hip Score (OHS) and Core Outcome Measures Index (COMI-Hip), were collected two years postoperatively. Data were analyzed with generalized multiple regression analysis.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1045 - 1051
1 Oct 2023
Turgeon TR Righolt CH Burnell CD Gascoyne TC Hedden DR Bohm ER

Aims

The primary aim of this trial was to compare the subsidence of two similar hydroxyapatite-coated titanium femoral components from different manufacturers. Secondary aims were to compare rotational migration (anteversion/retroversion and varus/valgus tilt) and patient-reported outcome measures between both femoral components.

Methods

Patients were randomized to receive one of the two femoral components (Avenir or Corail) during their primary total hip arthroplasty between August 2018 and September 2020. Radiostereometric analysis examinations at six, 12, and 24 months were used to assess the migration of each implanted femoral component compared to a baseline assessment. Patient-reported outcome measures were also recorded for these same timepoints. Overall, 50 patients were enrolled (62% male (n = 31), with a mean age of 65.7 years (SD 7.3), and mean BMI of 30.2 kg/m2 (SD 5.2)).


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1231 - 1237
1 Jul 2021
Manninen E Lainiala O Karsikas M Reito A Jämsä P Eskelinen A

Aims

To find out if there is an inverse association between estimated glomerular filtration rate (eGFR) and whole blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasties and renal insufficiency, suggesting that renal insufficiency could cause accumulation of Co and Cr in blood.

Methods

Out of 2,520 patients with 3,013 MoM hip arthroplasties, we identified 1,244 patients with whole blood Co, Cr, and creatinine measured within no more than a one-year interval. We analyzed the correlation of blood metal ion levels and eGFR to identify a potential trend of accumulating Co or Cr with decreasing eGFR.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 193 - 199
1 Feb 2022
Wang Q Wang H A G Xiao T Kang P

Aims

This study aimed to use intraoperative free electromyography to examine how the placement of a retractor at different positions along the anterior acetabular wall may affect the femoral nerve during total hip arthroplasty (THA) when undertaken using the direct anterior approach (THA-DAA).

Methods

Intraoperative free electromyography was performed during primary THA-DAA in 82 patients (94 hips). The highest position of the anterior acetabular wall was defined as the “12 o’clock” position (middle position) when the patient was in supine position. After exposure of the acetabulum, a retractor was sequentially placed at the ten, 11, 12, one, and two o’clock positions (right hip; from superior to inferior positions). Action potentials in the femoral nerve were monitored with each placement, and the incidence of positive reactions (defined as explosive, frequent, or continuous action potentials, indicating that the nerve was being compressed) were recorded as the primary outcome. Secondary outcomes included the incidence of positive reactions caused by removing the femoral head, and by placing a retractor during femoral exposure; and the incidence of femoral nerve palsy, as detected using manual testing of the strength of the quadriceps muscle.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1491 - 1496
1 Nov 2020
Buddhdev PK Vanhegan IS Khan T Hashemi-Nejad A

Aims

Despite advances in the treatment of paediatric hip disease, adolescent and young adult patients can develop early onset end-stage osteoarthritis. The aims of this study were to address the indications and medium-term outcomes for total hip arthroplasty (THA) with ceramic bearings for teenage patients.

Methods

Surgery was performed by a single surgeon working in the paediatric orthopaedic unit of a tertiary referral hospital. Databases were interrogated from 2003 to 2017 for all teenage patients undergoing THA with a minimum 2.3 year follow-up. Data capture included patient demographics, the underlying hip pathology, number of previous surgeries, and THA prostheses used. Institutional ethical approval was granted to contact patients for prospective clinical outcomes and obtain up-to-date radiographs. In total, 60 primary hips were implanted in 51 patients (35 female, 16 male) with nine bilateral cases. The mean age was 16.7 years (12 to 19) and mean follow-up was 9.3 years (2.3 to 16.8).


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1774 - 1782
1 Dec 2021
Divecha HM O'Neill TW Lunt M Board TN

Aims

The aim of this study was to determine if uncemented acetabular polyethylene (PE) liner geometry, and lip size, influenced the risk of revision for instability or loosening.

Methods

A total of 202,511 primary total hip arthroplasties (THAs) with uncemented acetabular components were identified from the National Joint Registry (NJR) dataset between 2003 and 2017. The effect of liner geometry on the risk of revision for instability or loosening was investigated using competing risk regression analyses adjusting for age, sex, American Society of Anesthesiologists grade, indication, side, institution type, surgeon grade, surgical approach, head size, and polyethylene crosslinking. Stratified analyses by surgical approach were performed, including pairwise comparisons of liner geometries.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1654 - 1661
1 Dec 2020
Perelgut ME Polus JS Lanting BA Teeter MG

Aims

The direct anterior (DA) approach has been associated with rapid patient recovery after total hip arthroplasty (THA) but may be associated with more frequent femoral complications including implant loosening. The objective of this study was to determine whether the addition of a collar to the femoral stem affects implant migration, patient activity, and patient function following primary THA using the DA approach.

Methods

Patients were randomized to either a collared (n = 23) or collarless (n = 26) cementless femoral stem implanted using the DA approach. Canal fill ratio (CFR) was measured on the first postoperative radiographs. Patients underwent a supine radiostereometric analysis (RSA) exam postoperatively on the day of surgery and at two, four, six, 12, 26, and 52 weeks postoperatively. Patient-reported outcome measures (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the 12-item Short Form Health Survey Mental and Physical Score, and University of California, Los Angeles (UCLA) Activity Score) were measured preoperatively and at each post-surgery clinic visit. Activity and function were also measured as the weekly average step count recorded by an activity tracker, and an instrumented timed up-and-go (TUG) test in clinic, respectively.


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 832 - 837
1 Jul 2020
Dover C Kuiper JH Craig P Shaylor P

Aims

We have previously demonstrated raised cobalt and chromium levels in patients with larger diameter femoral heads, following metal-on-polyethylene uncemented total hip arthroplasty. Further data have been collected, to see whether these associations have altered with time and to determine the long-term implications for these patients and our practice.

Methods

Patients from our previous study who underwent Trident-Accolade primary total hip arthroplasties using a metal-on-polyethylene bearing in 2009 were reviewed. Patients were invited to have their cobalt and chromium levels retested, and were provided an Oxford Hip Score. Serum ion levels were then compared between groups (28 mm, 36 mm, and 40 mm heads) and over time.


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 536 - 539
1 May 2019
Cassidy RS O hEireamhoin S Beverland DE

Aims

The aim of this retrospective audit was to determine the route of referral or presentation of patients requiring revision following primary total hip arthroplasty (THA).

Patients and Methods

A total of 4802 patients were implanted with an Orthopaedic Data Evaluation Panel (ODEP) 10A* cementless implant (Corail/Pinnacle) between 2005 and 2015; 80 patients with a mean age of 67.8 years (sd 10.8) underwent a subsequent revision. The primary outcome measure was route of referral for revision.


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 105 - 111
1 Jul 2020
Engh, Jr. CA McAsey CJ Cororaton AD Ho H Hopper, Jr. RH

Aims

The purpose of this study is to examine six types of bearing surfaces implanted at a single institution over three decades to determine whether the reasons for revision vary among the groups and how long it takes to identify differences in survival.

Methods

We considered six cohorts that included a total of 1,707 primary hips done between 1982 and 2010. These included 223 conventional polyethylene sterilized with γ irradiation in air (CPE-GA), 114 conventional polyethylene sterilized with gas plasma (CPE-GP), 116 crosslinked polyethylene (XLPE), 1,083 metal-on-metal (MOM), 90 ceramic-on-ceramic (COC), and 81 surface arthroplasties (SAs). With the exception of the COC, all other groups used cobalt-chromium (CoCr) femoral heads. The mean follow-up was 10 (0.008 to 35) years. Descriptive statistics with revisions per 100 component years (re/100 yr) and survival analysis with revision for any reason as the endpoint were used to compare bearing surfaces.


The Bone & Joint Journal
Vol. 101-B, Issue 2 | Pages 207 - 212
1 Feb 2019
Clavé A Gérard R Lacroix J Baynat C Danguy des Déserts M Gatineau F Mottier D

Aims

Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol.

Patients and Methods

A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group.


The Bone & Joint Journal
Vol. 101-B, Issue 11 | Pages 1438 - 1446
1 Nov 2019
Kong X Chai W Chen J Yan C Shi L Wang Y

Aims

This study aimed to explore whether intraoperative nerve monitoring can identify risk factors and reduce the incidence of nerve injury in patients with high-riding developmental dysplasia.

Patients and Methods

We conducted a historical controlled study of patients with unilateral Crowe IV developmental dysplasia of the hip (DDH). Between October 2016 and October 2017, intraoperative nerve monitoring of the femoral and sciatic nerves was applied in total hip arthroplasty (THA). A neuromonitoring technician was employed to monitor nerve function and inform the surgeon of ongoing changes in a timely manner. Patients who did not have intraoperative nerve monitoring between September 2015 and October 2016 were selected as the control group. All the surgeries were performed by one surgeon. Demographics and clinical data were analyzed. A total of 35 patients in the monitoring group (ten male, 25 female; mean age 37.1 years (20 to 46)) and 56 patients in the control group (13 male, 43 female; mean age 37.9 years (23 to 52)) were enrolled. The mean follow-up of all patients was 13.1 months (10 to 15).