Patient-reported outcomes after minimally invasive sacro-iliac joint surgery: a cohort study based on the Swedish Spine Registry.

BACKGROUND AND PURPOSE: There is conflicting evidence regarding treatment outcomes after minimally invasive sacroiliac joint fusion for long-lasting severe sacroiliac joint pain. The primary aim of our cohort study was to investigate change in patient-reported outcome measures (PROMs) after minimally invasive sacroiliac joint surgery in daily practice in the Swedish Spine Registry. Secondary aims were to explore the proportion of patients reaching a patient acceptable symptom score (PASS) and the minimal clinically important difference (MCID) for pain scores, physical function, and health-related quality of life outcomes; furthermore, to evaluate self-reported satisfaction, walking distance, and changes in proportions of patients on full sick leave/disability leave and report complications and reoperations. METHODS: Data from the Swedish Spine Registry was collected for patients with first-time sacroiliac joint fusion, aged 21 to 70 years, with PROMs available preoperatively, at 1 or 2 years after last surgery. PROMs included Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for low back pain (LBP) and leg pain, and EQ-VAS, in addition to demographic variables. We calculated mean change from pre- to postoperative and the proportion of patients achieving MCID and PASS. RESULTS: 68 patients had available pre- and postoperative data, with a mean age of 45 years (range 25-70) and 59 (87%) were female. At follow-up the mean reduction was 2.3 NRS points (95% confidence interval [CI] 1.6-2.9; P < 0.001) for LBP and 14.8 points (CI 10.6-18.9; P < 0.001) for ODI. EQ-VAS improved by 22 points (CI 15.4-30.3, P < 0.001) at follow-up. Approximately half of the patients achieved MCID and PASS for pain (MCID NRS LBP: 38/65 [59%] and PASS NRS LBP: 32/66 [49%]) and physical function (MCID ODI: 27/67 [40%] and PASS ODI: 24/67 [36%]). The odds for increasing the patient's walking distance to over 1 km at follow-up were 3.5 (CI 1.8-7.0; P < 0.0001), and of getting off full sick leave or full disability leave was 0.57 (CI 0.4-0.8; P = 0.001). In the first 3 months after surgery 3 complications were reported, and in the follow-up period 2 reoperations. CONCLUSION: We found moderate treatment outcomes after minimally invasive sacroiliac joint fusion when applied in daily practice with moderate pain relief and small improvements in physical function.

The effect of minimally invasive sacroiliac joint fusion compared with sham operation: study protocol of a prospective double-blinded multicenter randomized controlled trial.

Background and purpose - The sacroiliac joint is increasingly recognized as a cause of pain in 15-30% of patients with low back pain. Nonoperative management is not always successful and surgical treatment with fusion of the joint is increasingly recommended. According to the literature, minimally invasive fusion reduces pain and improves function compared with nonoperative treatment. It is, however, unclear to what extent the placebo effect influences these results. Patients and methods - The trial is designed as a prospective multi-center, double-blind, randomized shamsurgery controlled trial with 2 parallel groups. 60 patients with a suspected diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection are included according to the trial inclusion criteria. Patients are randomized with a 1:1 allocation into 2 groups of 30 patients each. The primary end-point is group difference in sacroiliac joint pain intensity on the operated side at 6 months postoperatively, measured by the Numeric Rating Scale. The main objective is to examine whether there is a difference in pain reduction between patients treated with a minimally invasive fusion of the sacroiliac joint compared with patients undergoing a sham operation. Results - Unblinding occurs after the completed 6-month follow-up. The primary analysis will be performed when all patients have completed 6 months' follow-up. Follow-ups are continued to at least 2 years postoperatively. Data from the different groups will be compared based on the "intention to treat" principle.

Reliability, validity and responsiveness of pelvic floor muscle surface electromyography and manometry.

INTRODUCTION AND HYPOTHESIS: Vaginal surface electromyography (sEMG) is commonly used to assess pelvic floor muscle (PFM) function and dysfunction but there is a lack of studies regarding the assessment properties. The aim of the study was to test the hypotheses that sEMG has good test-retest intratester reliability, good criterion validity and is responsive to changes compared to manometry. METHODS: PFM resting tone, maximum voluntary contraction (MVC) and endurance were measured in 66 women with pelvic floor dysfunction. One assessment by manometry was followed by two testing sessions with sEMG at baseline. After 4 to 42 weeks of supervised PFM strength training, 29 participants were retested with both devices. RESULTS: Median age of the participants was 41 years (range 24-83) and parity 2 (range 0-10). Very good test-retest intratester reliability was found for all three sEMG measurements. The correlation between sEMG and manometry was moderate for vaginal resting tone (r = 0.42, n = 66, p < 0.001) and strong for MVC (r = 0.66, n = 66, p < 0.001) and endurance (r = 0.67, n = 66, p < 0.001). Following the strength training period, participants demonstrated increased MVC and endurance measured with manometry, but not with sEMG. A significant reduction in resting tone was found only with sEMG. CONCLUSION: sEMG is reliable and correlates well with manometry. However, sEMG is not as responsive as manometry for changes in PFM MVC and endurance. For measurement of PFM resting tone, sEMG seems more responsive than manometry, but this requires further investigation.

Cross-cultural adaptation, reliability, and validity of a Chinese version of the pelvic girdle questionnaire.

BACKGROUND: The Pelvic Girdle Questionnaire (PGQ) is the only specific instrument designed to evaluate pain and activity limitations in pregnant or postpartum women with pelvic girdle pain (PGP). This study aimed to translate and culturally adapt the PGQ for Chinese patients and to verify the validation of the psychometric items of the PGQ in the Chinese population. METHODS: First, the translation and cultural adaptation process of the PGQ was conducted on the basis of international guidelines. Eighteen women suffering from PGP (11 pregnant women and 7 postpartum women) were enrolled in the pilot tests. Second, a total of 130 pregnant and postpartum women with PGP were enrolled to evaluate the validation of the psychometric items of the Chinese version. RESULTS: The calculated Cronbach's alphas demonstrated a high level of internal consistency for the Chinese version of the PGQ, ranging from 0.77 to 0.93. The convergent validity showed a high positive correlation between the PGQ total score and the Oswestry Disability Index (0.84) and Numeric Rating Scale (0.73) for pain intensity. Furthermore, a good discriminatory ability was found for the Chinese version of the PGQ for distinguishing women who needed treatment from those not (area under the curve [AUC] = 0.843, p < 0.001), but not for discriminating the pregnant and postpartum states (AUC = 0.488, p = 0.824). The results of test-retest showed good reproducibility for the total PGQ (ICC = 0.93), the PGQ activity subscale (ICC = 0.92), and the PGQ symptom subscale (ICC = 0.77). CONCLUSION: Our study presents the translation, validation and psychometric features of the Chinese version of the PGQ, showing good construct validity and discriminative power for assessing the consequences of PGP among pregnant or postpartum Chinese women.

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) is internationally recommended for prevention and treatment of urinary incontinence (UI) and pelvic organ prolapse (POP). However, there is lack of knowledge about PFMT among pregnant Nepalese women. The objectives of this study were to develop a PFMT programme and to assess the feasibility of the programme. METHODS: A feasibility study was conducted to address aspects of the PFMT programme provided to pregnant women attending antenatal check-ups at Kathmandu University Dhulikhel Hospital. The women were recruited consecutively from June 2017 to April 2018. The PFMT programme consisted of attending a minimum of four supervised PFMT follow-up visits after inclusion to the programme and performing PFMT daily at home. Feasibility was assessed in terms of the recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability (attendance to PFMT visits, PFMT adherence, participant experiences) of the programme. Data were collected using self-reported questionnaires. Educational material (video, leaflet, and exercise diary) was developed in Nepali. RESULTS: Among 253 women included, 144 (57%) attended four or more supervised PFMT visits. No significant differences were found in the symptoms of UI (0.89) and POP (0.44) between those attending and those not attending four PFMT visits. Half of the women adhered to 50-100% of PFMT daily at home. The supervised PFMT and the educational material motivated the women to daily PFMT. CONCLUSION: The PFMT programme was acceptable, at least to those living in the district of the study site. The results and experiences from the current study may guide implementation and future studies on the effectiveness of PFMT in Nepal.

Cross-Cultural Adaptation and Validation of the Nepali Version of the Pelvic Girdle Questionnaire.

OBJECTIVE: The purpose of this study was to translate, cross-culturally adapt, and assess the reliability and validity of the Pelvic Girdle Questionnaire (PGQ) in pregnant Nepalese women. METHODS: The cross-cultural adaptation process was conducted according to the Guillemin guidelines. Reliability and validity were assessed using cross-sectional design. The participants responded to questionnaires of sociodemographics, the Nepali version of the PGQ, the Oswestry Disability Index, the Patient-Specific Functional Scale, the 5-item version of the Edinburgh Depression Scale, and the Numerical Pain Rating Scale. The internal consistency was assessed with Cronbach's alpha. The test-retest reliability was calculated using the intraclass correlation coefficient and smallest detectable change. Construct validity was assessed by testing 9 a priori hypotheses that examine correlations between the PGQ activity and symptom subscales, and also among the PGQ subscales and Oswestry Disability Index, Numerical Pain Rating Scale, Patient-Specific Functional Scale, and 5-item version of the Edinburgh Depression Scale. Spearman and Pearson's correlation were used to assess the correlations. RESULTS: A sample of 111 pregnant women were included in the study. The Cronbach's alpha for the Nepali version of the total PGQ was good (α = 0.83), and the test-retest reliability was acceptable (ICC2.1, 0.72) with a measurement error of SDC95% 18.6 points. Seven of the 9 hypotheses found support, which confirms acceptable construct validity of the Nepali PGQ. CONCLUSION: The Nepali version of the PGQ is a reliable and valid tool for assessing pelvic girdle pain in pregnant Nepalese women.

Prevalence and severity of low back- and pelvic girdle pain in pregnant Nepalese women.

BACKGROUND: Low back pain (LBP) and pelvic girdle pain (PGP) are commonly reported during pregnancy and are known to affect pregnant women's well-being. Still, these conditions are often considered to be a normal part of pregnancy. This study assesses the prevalence and severity of LBP and/or PGP among pregnant Nepalese women, as well as exploring factors associated with LBP and PGP. METHODS: A cross-sectional study with successive recruitment of pregnant women was conducted at two district hospitals in Nepal from May 2016 to May 2017. The data was collected using self-reported questionnaires. Univariate and multivariate logistic regression were used to assess the associations between independent variables and LBP and/or PGP. RESULTS: A total of 1284 pregnant women were included in the study. The reported prevalence of pregnancy-related LBP and/or PGP was 34%. Pain intensity was high with a mean score (standard deviation) of 6 (2). The median (25th-75th percentiles) disability scores according to the total Pelvic Girdle Questionnaire and Oswestry Disability Index were 20 (10-32) and 30 (21-38), respectively. Even though only 52% of the women believed that the pain would disappear after delivery, concern about LBP and/or PGP was reported to be low (median 2 (0-4) (Numeric Rating Scale 0-10)). In the final model for women with LBP and/or PGP the adjusted odds ratios were for body mass index (20-24, 25-30, > 30) 0.7 (95% confidence interval (CI), 0.44-1.21), 1.1 (95% CI, 0.66-1.83), and 1.5 (95% CI, 0.78-2.94) respectively, for pelvic organ prolapse symptoms 6.6 (95% CI, 4.93-8.95) and for women with educated husbands (primary or secondary, higher secondary or above) 1.1 (95% CI, 0.53-2.16) and 1.7 (95% CI, 0.84-3.47), respectively. CONCLUSIONS: Pregnant Nepalese women commonly report LBP and/or PGP. The women experienced low disability despite severe pain intensity and poor beliefs in recovery after delivery.

Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study.

BACKGROUND: Pelvic Girdle Pain (PGP) is an important cause of disability and economic cost worldwide. There is a need for effective preventative and management strategies. Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult. A Core Outcome Set (COS) can address this problem by ensuring that data are relevant, useful and usable for making well-informed healthcare choices. The aim of this study is to develop a consensus-based PGP-COS, including agreement on methods (e.g. instruments) for measuring the construct outcomes in the COS for use in research and clinical practice. Furthermore, as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey, or, whether using different rating scales in a Delphi survey impacts on the final COS, we propose to embed two methodological studies within the PGP-COS development process to address these questions. METHODS: The PGP-COS study will include five phases: (1) A systematic review of the literature and semi-structured interviews with 15 patients (three countries) to form the initial list of outcomes for the Delphi survey; (2) A 3-round Delphi including patients, clinicians, researchers and service providers; (3) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey; (4) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS; (5) Global dissemination. To address the methodological questions, we will assess the number and type of outcomes, in the final PGP-COS, that were exclusively derived from the interviews. Secondly, we will randomise Delphi survey participants to either a 5-point or 9-point importance rating scale, and examine potential differences in 'important' ratings between the groups. DISCUSSION: There is currently no COS for measuring/monitoring PGP in trials and clinical practice. A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally. CORE OUTCOME SET REGISTRATION: This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 ( http://www.comet-initiative.org/studies/details/958 ).

Cross-cultural Adaptation of the Pelvic Girdle Questionnaire for the Polish Population.

OBJECTIVE: The purpose of this study was to translate and culturally adapt the Pelvic Girdle Questionnaire (PGQ) into Polish to allow pelvic girdle pain (PGP) assessment in Polish women. METHODS: The translation process comprised 4 stages: forward translation, backward translation, committee review, and pretest. We then conducted a pilot study of the final version of the questionnaire in 49 women (mean age: 31.2 years, standard deviation: 3.74 years) who had PGP when pregnant or within a year postpartum. RESULTS: The internal consistency of the newly created questionnaire assessed with Cronbach's α was 0.916. CONCLUSION: The internal consistency of the process of translation and cross-cultural adaptation of the Polish version of the PGQ was satisfactory. The Polish version of the PGQ may be used both in clinical practice and for research among Polish women with PGP.

Validation of the French-Canadian Pelvic Girdle Questionnaire.

OBJECTIVE: Pain in the pelvic girdle area is commonly reported during pregnancy and the postpartum period, and its impact on quality of life is considerable. The Pelvic Girdle Questionnaire (PGQ), developed in 2011 in Norway, is the only condition-specific tool assessing pelvic girdle pain-related symptoms and disability. The questionnaire was recently translated and adapted for the French-Canadian population. The objective of this study was to assess the measurement properties of the previously translated French-Canadian PGQ. METHODS: Eighty-two women with pelvic girdle pain were included in this validation study. The French-Canadian PGQ, pain intensity Numeric Rating Scale, and Oswestry Disability Index were completed by participants at baseline, 48 hours later, and 3 to 6 months later to assess test-retest reliability, construct validity, responsiveness, floor and ceiling effects, and internal consistency. RESULTS: Reliability analyses indicated an intraclass correlation coefficient of 0.841 (95% confidence interval [CI] 0.750-0.901) for the global score. Construct validity analyses indicated a Spearman rank correlation coefficient of 0.696 with the Oswestry Disability Index. Responsiveness analyses identified an effect size of 0.908 (95% CI 0.434-1.644) and an area under the receiver operating characteristics curve of 0.823 (95% CI 0.692-0.953). There was no floor or ceiling effect, and internal consistency analyses indicated a Cronbach α of .933 for the activity subscale and .673 for the symptom subscale. CONCLUSION: Overall, the French-Canadian version of the PGQ is reliable, valid, and responsive, suggesting that it can be implemented in both research and clinical settings to assess functional limitations in pregnant and postpartum women.

Analysis of Test-Retest Reliability, Construct Validity, and Internal Consistency of the Brazilian Version of the Pelvic Girdle Questionnaire.

OBJECTIVE: The purpose of this study was to evaluate test-retest reliability, construct validity, and internal consistency of the Brazilian version of the Pelvic Girdle Questionnaire (PGQ-Brazil). METHODS: Analysis of the measurement properties was carried out in 4 steps. Step 1 was the pilot study, on which basis 4 hypotheses were formulated. These hypotheses were tested during the next step (construct validity, step 2) by completion of the questionnaire by the 2 groups (in pain [n = 105] and not in pain [n = 52]). For implementation of the PGQ-Brazil in the group with pain, we calculated the internal consistency (step 3) and, 7 days later, test-retest reliability (step 4) by re-application of the instrument in this group. RESULTS: First, the PGQ-Brazil was able to discriminate between these groups (construct validity). Second, test-retest reliability (intraclass correlation coefficients for Activities subscale [0.97 with 95% confidence interval of 0.95-0.98] and Symptoms subscale [0.98 with 95% confidence interval of 0.97-0.98] and κ coefficient between 0.50 and 0.89 for the items) was found to be good; the Bland-Altman test indicated satisfactory agreement. The Rasch analysis indicated good internal consistency, and the instrument's ability to divide the participants into at least 3 levels of skills was confirmed. In contrast, a ceiling effect was observed, as 24% of pregnant women exhibited skills superior to what the PGQ-Brazil could evaluate. CONCLUSIONS: The PGQ-Brazil had good internal consistency, test-retest reliability, and construct validity in assessment of limitations in activities and symptoms of pregnant women with pelvic girdle pain.

Transcultural adaptation and psychometric validation of a Spanish-language version of the "Pelvic Girdle Questionnaire".

BACKGROUND: The Pelvic Girdle Questionnaire is the only instrument designed to assess pain and disability specifically in pregnant or postpartum women with pelvic girdle pain. The objective of this study was the adaptation to the Spanish language and analysis of the psychometric properties of the Pelvic Girdle Questionnaire. METHODS: This is a descriptive cross-sectional study divided into two phases. In the first phase, a translation and adaptation process was performed according to international guidelines. Secondly, the analysis of the properties of the Spanish version was conducted using a sample of 125 pregnant or postpartum women suffering from pelvic girdle pain. Participants completed the Spanish version along with five other measurement instruments through an online platform. Internal consistency, construct validity, test-retest reliability, the ceiling and floor effects, responsiveness and discriminatory ability of the Spanish version were analysed. RESULTS: The Spanish version of the Pelvic Girdle Questionnaire showed high internal consistency with Cronbach's alpha = 0.961, and an intraclass correlation coefficient of 0.962. The convergent validity showed high positive correlation with other questionnaires used. ROC curves showed no discriminatory capacity for number of sites of pain or pregnancy/post-partum state. CONCLUSIONS: This article presents the translation, validation and psychometric properties of the Spanish version of the Pelvic Girdle Questionnaire, that has proved to be an appropriate and valid assessment tool of disability due to pelvic girdle pain in pregnant and postpartum women.

Exercise level before pregnancy and engaging in high-impact sports reduce the risk of pelvic girdle pain: a population-based cohort study of 39†184 women.

OBJECTIVE: To examine whether an association exists between exercise levels pre-pregnancy and pelvic girdle pain in pregnancy. Pelvic girdle pain in pregnancy has been associated with physical inactivity, a risk factor for adverse pregnancy outcomes. METHODS: We used data from a population-based cohort study including 39 184 nulliparous women with a singleton pregnancy enrolled in the Norwegian Mother and Child Cohort study. Pre-pregnancy exercise frequency and types were assessed by questionnaire in pregnancy week 17. Pelvic girdle pain, defined as combined pain in the anterior pelvis and in the posterior pelvis bilaterally, was self-reported in pregnancy week 30. Multivariable Poisson regression estimated risks of pelvic girdle pain associated with pre-pregnancy exercise. We examined a dose-response association of prepregnancy exercise frequency using restricted cubic splines. A test for non-linearity was also conducted. Final models were adjusted for pre-pregnancy BMI, age, education, history of low back pain and history of depression. RESULTS: 4069 women (10.4%) reported pelvic girdle pain in pregnancy and the prevalence among women who were non-exercisers prepregnancy was 12.5%. There was a non-linear association for pre-pregnancy exercise and risk of pelvic girdle pain (test for non-linearity, p=0.003). Compared to non-exercisers, women exercising 3-5 times weekly pre-pregnancy had a 14% lower risk of developing pelvic girdle pain in pregnancy (aRR 0.86, 95% CI 0.77 to 0.96). Taking part in high-impact exercises such as running, jogging, orienteering, ballgames, netball games and high-impact aerobics were associated with less risk of pelvic girdle pain. SUMMARY: Women who exercise regularly and engage in high-impact exercises before the first pregnancy may have a reduced risk of pelvic girdle pain in pregnancy.

Exercise and pregnancy in recreational and elite athletes: 2016 evidence summary from the IOC expert group meeting, Lausanne. Part 2-the effect of exercise on the fetus, labour and birth.

This is Part 2 of 5 in the series of evidence statements from the IOC expert committee on exercise and pregnancy in recreational and elite athletes. Part 1 focused on the effects of training during pregnancy and on the management of common pregnancy-related symptoms experienced by athletes. In Part 2, we focus on maternal and fetal perinatal outcomes.

Cross-cultural Adaptation of the Pelvic Girdle Questionnaire for the French-Canadian Population.

OBJECTIVE: The Pelvic Girdle Questionnaire (PGQ) is the only condition-specific tool assessing activity limitations and symptoms for those with pelvic girdle pain (PGP). It is simple to administer and can be used in research and clinical settings during pregnancy and postpartum periods; however, there currently is no version for the French-Canadian population. The aim of this study was to translate and culturally adapt the PGQ for the French-Canadian population. METHODS: The French-Canadian translation and adaptation of the PGQ was completed following a 4-stage approach: (1) forward translation, (2) synthesis, (3) expert committee review, and (4) testing of the prefinal version of the questionnaire. The testing stage was conducted with a cohort of 34 women, aged 18 to 45 years, who experienced PGP over the span of pregnancy or during the first year postpartum. RESULTS: The global understanding of the PGP concept was rated as either "Fair" (41.2%) or "Good" (32.4%) by the majority of participants, which led to the consensual decision to add an illustration of the pelvic girdle region to the final version of the French-Canadian PGQ. Only 1 item ("Has your leg/have your legs given way?") was reported as unclear by 12 participants (35.3%). The expert committee unanimously agreed to add a brief explanation of the term "given way" to the final version to ensure proper understanding of the question. CONCLUSIONS: The current study yielded a satisfactory French-Canadian translation of the PGQ.

Pelvic joint fusion in patients with severe pelvic girdle pain - a prospective single-subject research design study.

BACKGROUND: The fusion of the pelvic joints in patients with severe pelvic girdle pain (PGP) is a controversial and insufficiently studied procedure. The aims of this study were to evaluate physical function and pain after sacroiliac joint (SIJ) fusion. METHODS: A single-subject research design study with repeated measurements was conducted; pre-operatively and at 3, 6 and 12 months post-operatively. The outcome measures considered were the Oswestry disability index (ODI), visual analogue scale (VAS), and SF-36. Eight patients with severe PGP received open-accessed unilateral anterior SIJ fusion and fusion of the pubic symphysis. RESULTS: Seven patients reported positive results from the surgery. At 1 year post-operation, significant (p < 0.001) reductions in ODI (54 to 37) and VAS (82 to 57) were reported. The physical functioning, bodily pain, and social functioning scores in the SF-36 were also improved. CONCLUSION: Positive and significant changes in disability and pain at 1 year after SIJ fusion were observed. Despite these positive results, open accessed anterior fusion of the SIJ was associated with adverse events and complications such as infection and nerve damage.

The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial.

Background: Minimally invasive fusion of the sacroiliac joint as treatment for low back pain may reduce pain and improve function compared to non-operative treatment, although clear evidence is lacking. The aim of this trial was to evaluate the effect of minimally invasive sacroiliac joint fusion compared to sham surgery on sacroiliac joint pain reduction. Methods: In this double-blind randomized sham surgery-controlled trial patients with clinical diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection were included at two university hospitals in Sweden and Norway. Patients were randomized by the operating surgeon at each site to minimally invasive sacroiliac joint fusion or sham surgery. The primary endpoint was group difference in sacroiliac joint pain on the operated side at six months postoperatively, measured by the Numeric Rating Scale (0-10). Un-blinding and primary analysis were performed when all patients had completed six months follow-up. The trial is closed for new participants and was registered at clinicaltrials.gov: NCT03507049. Findings: Between September 1st, 2018 and October 22nd, 2021, 63 patients were randomized, 32 to the surgical group, 31 to the sham group. Mean age was 45 years (range 26-63) and 59 of 63 (94%) patients were female. The mean reduction in the operated sacroiliac joint from baseline to six months postoperative was 2.6 Numeric Rating Scale points in the surgical group and 1.7 points in the sham group (mean between groups difference -1.0 points; 95% CI, -2.2 to 0.3; p = 0.13). Interpretation: This double-blind randomized controlled trial could not prove that minimally invasive fusion of the sacroiliac joint was superior to sham surgery at six months postoperative. Funding: Sophies Minde Ortopedi supported a clinical research position for Engelke Marie Randers. Region Stockholm supported the cost for the Swedish ethical application and a clinical research appointment for Paul Gerdhem.

Osseointegration of minimally invasive sacroiliac joint fixation implants-A human retrieval study.

Minimally invasive sacroiliac joint fusion has become increasingly prevalent and is described to reduce pain and improve function. In some patients, pain can recur several months after primary surgery. Lack of early implant osseointegration might be a cause of pain and hence an indication for revision surgery. Triangular titanium implants are the most documented implant for minimally invasive sacroiliac joint fusion. There is, however, no knowledge of how triangular titanium implants osseointegrate in humans and whether fusion is induced over the sacroiliac joint. During planned revision surgery due to recurrent pain, six triangular titanium implants were retrieved from six different patients at median 9 months from primary surgery. All six implants were scanned using microcomputed tomography. The presence or absence of bone in-growth, on-growth, and through-growth of the implants was evaluated as an indication of implant osseointegration. Three of six implants showed no or minor signs of osseointegration. Of the three remaining implants, one showed partial osseointegration and two implants showed high degrees of osseointegration. This study showed that triangular titanium implants can osseointegrate into host bone in humans. When osseointegration occurs, triangular titanium implants can give fusion across the sacroiliac joint.

Mode of delivery and persistence of pelvic girdle syndrome 6 months postpartum.

OBJECTIVE: We sought to study the association between mode of delivery and persistent pelvic girdle syndrome (PGS) (pain in anterior and bilateral posterior pelvis) 6 months postpartum. STUDY DESIGN: We followed up 10,400 women with singleton deliveries in the Norwegian Mother and Child Cohort Study who reported PGS in pregnancy week 30 (1999 through 2008). Data were obtained by 3 self-administered questionnaires and linked to the Medical Birth Registry of Norway. RESULTS: Planned cesarean section was associated with the presence of severe PGS 6 months postpartum (adjusted odds ratio [OR], 2.3; 95% confidence interval [CI], 1.4-3.9). In women who used crutches during pregnancy, emergency (adjusted OR, 2.0; 95% CI, 1.0-4.0) and planned (adjusted OR, 3.3; 95% CI, 1.9-5.9) cesarean section were each associated with severe PGS. CONCLUSION: The results suggest an increased risk of severe PGS 6 months postpartum in women who underwent a cesarean section vs women who had an unassisted vaginal delivery.

Pelvic joint fusions in patients with chronic pelvic girdle pain: a 23-year follow-up.

PURPOSE: Fusion of the sacroiliac joints (SIJ) has been a treatment option for patients with severe pelvic girdle pain (PGP). The primary aims were to evaluate the long-term outcomes in patients who underwent SIJ fusion and to compare 1-year outcomes with long-term outcomes. The secondary aim was to compare patients who underwent SIJ fusion with a comparable group who did not. METHODS: This study includes fifty patients that underwent SIJ fusion between 1977 and 1998. Function (the Oswestry disability index; ODI), pain intensity (visual analogue scale; VAS) and health-related quality of life (SF-36) were determined according to a patient-reported questionnaire. The questionnaire scores were compared with previously recorded 1-year outcomes and with questionnaire scores from a group of 28 patients who did not undergo SIJ fusion. RESULTS: The patients who underwent SIJ fusion reported a mean ODI of 33 (95 % CI 24-42) and a mean VAS score of 54 (95 % CI 46-63) 23 years (range 19-34) after surgery. Regarding quality of life, the patients reported reduced physical function, but mental health was not affected in the same manner. The patients with successful 1-year outcomes (48 %) retained significantly improved function and reduced pain levels compared with the subgroup of patients with unsuccessful 1-year outcomes (28 %). The patients who underwent surgery did not differ from the non-surgery group in any outcome at the long-term follow-up. CONCLUSIONS: Patients treated with SIJ fusion had moderate disability and pain 23 years after surgery, and the 1-year outcomes were sustained 23 years after surgery. Although many fused patients reported good outcome, this group did not differ from the comparable non-surgical group.