Effect of Osteochondroplasty on Time to Reoperation After Arthroscopic Management of Femoroacetabular Impingement: Analysis of a Randomized Controlled Trial.

Background: A subset of patients with femoroacetabular impingement (FAI) fail arthroscopic management. It is not clear which patients will fail surgical management; however, several surgical and patient factors, such as type of procedure and age, are thought to be important predictors. Purpose: This time-to-event analysis with a 27-month follow-up analysis compared the effect of (1) arthroscopic osteochondroplasty with or without labral repair versus (2) arthroscopic lavage with or without labral repair on the time to reoperation in adults aged 18 to 50 years with FAI. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Eligible participants had been randomized in a previous study trial to a treatment of arthroscopic osteochondroplasty or arthroscopic lavage with or without labral repair. Using the comprehensive data set from the Multinational Femoroacetabular Impingement Randomized controlled Trial, all reoperations until 27 months after surgery were identified. The analysis was conducted using a Cox proportional hazards model, with percentage of patients with a reoperation evaluated in a time-to-event analysis as the outcome. The independent variable was the procedure, with age and impingement subtype explored as potential covariates. The effects from the Cox model were expressed as the hazard ratio (HR). All tests were 2-sided, with an alpha level of .05. Results: A total of 108 patients in the osteochondroplasty group and 106 patients in the lavage group were included. The mean age of the patients included in the study was 36 ± 8.5 years. Overall, 27 incident reoperations were identified within the 27-month follow-up, with an incidence rate of 6 per 100 person-years. Within the osteochondroplasty group, 8 incident reoperations were identified (incidence rate, 3.4 per 100 person-years), while within the lavage group, 19 incident reoperations were identified (incidence rate, 8.7 per 100 person-years). The hazard of reoperation for patients undergoing osteochondroplasty was 40% of that of patients undergoing lavage (HR, 0.40 [95% CI, 0.17-0.91] P = .029). Conclusion: This study demonstrated that for adults between the ages of 18 and 50 years with FAI, arthroscopic osteochondroplasty was associated with a 2.5-fold decrease in the hazard of reoperation at any point in time compared with arthroscopic lavage. Registration: NCT01623843 (ClinicalTrials.gov identifier).

Functional results of total-knee arthroplasty versus medial unicompartmental arthroplasty: two-year results of a randomised, assessor-blinded multicentre trial.

OBJECTIVE: The primary objective of the trial was to assess the clinical effectiveness of medial unicompartmental knee arthroplasty versus total knee arthroplasty in patients with isolated medial osteoarthritis of the knee. DESIGN: Prospective, randomised, 2 years, assessor-blind, multicentre, superiority trial. SETTING: The patients were enrolled between December 2015 and May 2018 from the outpatient clinics of three public high-volume arthroplasty hospitals (Finland). PARTICIPANTS: We recruited 143 patients with symptomatic-isolated medial osteoarthritis of the knee needing an arthroplasty procedure. All the patients were suitable for both unicompartmental and total knee arthroplasties. Population was selected as the end-stage-isolated medial osteoarthritis. INTERVENTIONS: All patients, randomized 1:1, received a medial unicompartmental arthroplasty or a total knee arthroplasty through a similar midline skin incision. Patients were blinded to the type of arthroplasty for the whole 2 years of follow-up. MAIN OUTCOME MEASURES: Primary outcome measure was between-group differences in the Oxford Knee Score (OKS) and secondary outcome Knee injury and Osteoarthritis Score (KOOS) at 2 years postoperatively. The changes within and between the groups were analysed with analysis of variance for repeated measurements. RESULTS: The primary outcome was comparable for medial unicompartmental arthroplasty and total knee arthroplasty at 2 years. The mean difference in the OKS between the groups was 1.6 points (95% CI -0.7 to 3.9). In the KOOS subscales, the mean difference between the groups was 0.1 points (95% CI -4.8 to 5.0) for pain, 7.8 points (95% CI 1.5 to 14.0) for symptoms, 4.3 points (95% CI -0.6 to 9.2) for function in daily living, 4.3 points (95% CI -3.0 to 11.6) for function in sports, and 2.1 points (95% CI -4.8 to 9.1) for knee-related quality of life. CONCLUSIONS: The recovery after unicompartmental knee arthroplasty was faster compared with total knee arthroplasty, but unicompartmental arthroplasty did not provide a better patient-reported outcome at 2 years. TRIAL REGISTRATION NUMBER: NCT02481427.

Osteochondroplasty and Labral Repair for the Treatment of Young Adults With Femoroacetabular Impingement: A Randomized Controlled Trial.

BACKGROUND: Femoroacetabular impingement (FAI) is a condition known to cause hip pain in young adults. PURPOSE: To evaluate the efficacy of the surgical correction of FAI via arthroscopic osteochondroplasty with or without labral repair compared with arthroscopic lavage of the hip joint with or without labral repair. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 220 male and female participants aged 18 to 50 years with nonarthritic FAI suitable for surgical treatment were recruited for the trial at 10 clinical centers in Canada, Finland, and Denmark between October 2012 and November 2017, of whom 214 were included in the final analysis. In the osteochondroplasty group, cam- and/or pincer-type lesions were resected using fluoroscopic guidance. In the lavage group, the joint was washed out with 3 L of normal saline. Surgeons were instructed to repair the labrum in both groups if it was mechanically unstable once probed, showing visible displacement or chondrolabral separation. The primary outcome was patient-reported pain (using the 100-point visual analog scale [VAS]) at 12 months. Secondary outcomes included hip function (Hip Outcome Score [HOS] and International Hip Outcome Tool), physical and mental health (12-Item Short Form Health Survey), and health utility (EuroQol-5 Dimensions) at 12 months as well as any reoperations and other hip-related adverse events at 24 months. RESULTS: At 12 months, there was no difference in pain (VAS) between the groups (mean difference [MD], 0.11 [95% CI, -7.22 to 7.45]; P = .98). Also, 88.3% (189/214) of participants had a labral tear, of which 60.3% were repaired. For the secondary outcomes, there were no significant differences between treatment groups, with the exception of the HOS activities of daily living domain in which lavage showed significant improvement compared with osteochondroplasty (MD, -5.03 [95% CI, -10.40 to -0.03]; P = .049). By 24 months, there were significantly fewer reoperations reported in the osteochondroplasty group (8/105) than the lavage group (19/104) (odds ratio, 0.37 [95% CI, 0.15-0.89]; P = .026). The primary reasons for a reoperation included hip pain (15/27; 55.6%) and a reinjury of the labrum (11/27; 40.7%). CONCLUSION: Both the osteochondroplasty and the lavage groups with or without labral repair for FAI had significantly improved pain or function significantly at 1 year. By 2 years, the reoperation rate was significantly lower in the osteochondroplasty group. REGISTRATION: NCT01623843 (ClinicalTrials.gov identifier).

High Revision Rate for Large-head Metal-on-metal THA at a Mean of 7.1 Years: A Registry Study.

BACKGROUND: Large-diameter head metal-on-metal (MoM) THA has largely been abandoned as a result of higher than anticipated revision rates. However, the majority of these implants are still in situ. Although earlier reports from the Finnish Arthroplasty Register noted similar short-term survivorship between large-diameter head MoM THA and conventional cemented THA, longer term survivorship of this population is unclear. Although reported revision rates for this implant group have been high, the majority of these implants have not been revised and followup is important to improve long-term management. QUESTIONS/PURPOSES: The purposes of this study were (1) to compare the 10-year competing risk survivorship of large-diameter head MoM THA with the survivorship of conventional THA in the Finnish Arthroplasty Register; (2) to report the large-diameter head MoM THA survival at the manufacturer/brand level; and (3) to identify the most common reasons for revision of large-diameter head MoM THA in the Finnish Arthroplasty Register. METHODS: The six most commonly used large-diameter head (≥ 38 mm) MoM THA devices in Finland between years 2004 and 2013 were selected (n = 10,959 implants). The completeness of the Finnish Registry is > 95% in primary THA and patients are censored from the date of death or at the point of emigration; followup continued until the end of 2015. The conventional THA control group consisted of the two most frequently used devices (Vision/Bimetric and ABG II/ABG II) with metal-on-polyethylene or ceramic-on-ceramic bearing surfaces implanted between 2002 and 2013 (n = 5177). The study group was formed by selecting all pairs of large-diameter head MoM and reference THA protheses within the same age group ( < 49, 50-54, 55-59, 60-64, 65-69, 70-74, and 75+ years), sex, diagnosis (osteoarthritis, other), and hospital yearly operation count (< 100 operations yearly, ≥ 100 operations yearly); 5166 matched pairs were identified. Revision for any reason was considered as the failure endpoint of followup. Implant survival (the proportion not revised) was calculated from corresponding cumulative incidence function adjusted for patient death as a competing event for revision. Large-diameter head MoM implant group revision hazard ratios with 95% confidence intervals were estimated with age group, sex, diagnosis, and hospital yearly operation count as confounding factors in a Cox regression model. RESULTS: Ten-year survivorship free from all-cause revision was lower for THAs that used a large-diameter femoral head than it was for the control group of conventional THA (83% [95% confidence interval {CI}, 82%-84%] versus 92% [95% CI, 91%-93%]). At the implant level, every large-diameter head MoM THA had a higher risk for revision compared with the conventional THA control group from the fourth postoperative year onward. The highest survival of MoM THA was 88% (95% CI, 86%-90%) for the ReCap/Bimetric and the lowest survival was 46% (95% CI, 41%-51%) for the recalled ASR with either the Summit® or Corail® stem. The most common revision reason in the MoM THA group was adverse reaction to metal debris, whereas dislocation was predominant in the conventional THA control group. CONCLUSIONS: The revision rate for all large-diameter head MoM THAs in this timeframe in the Finnish Arthroplasty Register is unacceptably high and in our view supports the decision to abandon their use. In agreement with the directives of other national organizations, we recommend regular followup of all patients with large-diameter head MoM THA. Based on our results, strict guidelines for followup should be maintained over the lifetime of the implant to assess patient symptoms and recommend revision when indicated. LEVEL OF EVIDENCE: Level III, therapeutic study.

Pelvic incidence and hip disorders.

Background and purpose - The role of pelvic incidence in hip disorders is unclear. Therefore, we undertook a literature review to evaluate the evidence on that role. Methods - A search was carried out on MEDLINE, SCOPUS, CENTRAL, and CINAHL databases. Quantitative analysis was based on comparison with a reference population of asymptomatic subjects. Results - The search resulted in 326 records: 15 studies were analyzed qualitatively and 13 quantitatively. The estimates of pelvic incidence varied more than 10 degrees from 47 (SD 3.7) to 59 (SD 14). 2 studies concluded that higher pelvic incidence might contribute to the development of coxarthrosis while 1 study reported the opposite findings. In 2 studies, lower pelvic incidence was associated with a mixed type of femoroacetabular impingement. We formed a reference population from asymptomatic groups used or cited in the selected studies. The reference comprised 777 persons with pooled average pelvic incidence of 53 (SD 10) degrees. The estimate showed a relatively narrow 95% CI of 52 to 54 degrees. The 95% CIs of only 4 studies did not overlap the CIs of reference: 2 studies on coxarthrosis, 1 on mixed femoroacetabular impingement, and 1 on ankylosing spondylitis Interpretation - We found no strong evidence that pelvic incidence plays any substantial role in hip disorders. Lower pelvic incidence may be associated with the mixed type of femoroacetabular impingement and hip problems amongst patients with ankylosing spondylitis. The evidence on association between pelvic incidence and coxarthrosis remained inconclusive.

Reliability of Sagittal Spinopelvic Alignment Measurements After Total Hip Arthroplasty.

STUDY DESIGN: This is a observational study. OBJECTIVE: To evaluate the reliability of measuring sagittal spinopelvic alignment after hip arthroplasty. SUMMARY OF BACKGROUND DATA: Pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT), and lumbar lordosis (LL) are widely used in planning the treatment of people with spinal and hip disorders. Previously, these measures have proved reliable when hip heads are intact. Thus far, it is not known whether they are also reliable after total hip replacement. MATERIALS AND METHODS: Two observers assessed PI, SS, PT, and LL in the radiographs of 97 patients who had undergone total hip replacement. Test-retest (intraobserver) and interobserver reliability were estimated. RESULTS: The intraclass correlation coefficient ranged from 0.92 to 0.97 and 0.85 to 0.94 for the intraobserver and interobserver settings, respectively, indicating an almost perfect correlation between observers or observations. The absolute intrarater measurement errors were 1.41 [95% confidence interval (CI), 0.98-2.03) for PI, 1.16 (95% CI, 0.78-1.74) for SS, 0.49 (95% CI, 0.31-0.76) for PT, and 1.75 (95% CI, 1.22-2.51) degrees for LL. The respective interrater figures were 2.82 (95% CI, 2.04-3.9), 2.44 (95% CI, 1.78-3.35), 0.73 (95% CI, 0.48-1.13), and 2.28 (95% CI, 1.55-3.34) degrees. CONCLUSIONS: It seems that total hip arthroplasty does not affect the reliability of spinopelvic sagittal alignment measurements. LEVEL OF EVIDENCE: Level II.

Poor 10-year survivorship of hip resurfacing arthroplasty.

Background and purpose - In a previous registry report, short-term implant survival of hip resurfacing arthroplasty (HRA) in Finland was found to be comparable to that of total hip arthroplasty (THA). Since then, it has become evident that adverse reactions to metal debris (ARMDs) may also be associated with HRA, not only with large-diameter head metal-on-metal THA. The aim of the study was to assess medium- to long-term survivorship of HRA based on the Finnish Arthroplasty Register (FAR). Patients and methods - 5,068 HRAs performed during the period 2001-2013 in Finland were included. Kaplan-Meier survival analysis was used to calculate survival probabilities and their 95% confidence intervals (CIs). Cox multiple regression, with adjustment for age, sex, diagnosis, femoral head size, and hospital volume was used to analyze implant survival of HRA devices with revision for any reason as endpoint. The reference group consisted of 6,485 uncemented Vision/Bimetric and ABG II THAs performed in Finland over the same time period. Results - The 8-year survival, with any revision as an endpoint, was 93% (CI: 92-94) for Birmingham Hip Resurfacing (BHR), 86% (CI: 78-94) for Corin, 91% (CI: 89-94) for ReCap, 92% (CI: 89-96) for Durom, and was 72% (CI: 69-76) for the Articular Surface Replacement (ASR). The 10-year survival, with any revision as an endpoint, for reference THAs was 92% (CI: 91-92) and for all HRAs it was 86% (CI: 84-87%). Female HRA patients had about twice the revision risk of male patients. ASR had an inferior outcome: the revision risk was 4-fold higher than for BHR, the reference implant. Interpretation - The 10-year implant survival of HRAs is 86% in Finland. According to new recommendations from NICE (The National Institute for Health and Care Excellence), an HRA/THA should have a revision rate of 5% or less at 10 years. None of the HRAs studied achieved this goal.

Adverse reaction to metal debris after Birmingham hip resurfacing arthroplasty.

BACKGROUND AND PURPOSE: Concern has emerged about local soft-tissue reactions after hip resurfacing arthroplasty (HRA). The Birmingham Hip Resurfacing (BHR) was the most commonly used HRA device at our institution. We assessed the prevalence and risk factors for adverse reaction to metal debris (ARMD) with this device. PATIENTS AND METHODS: From 2003 to 2011, BHR was the most commonly used HRA device at our institution, with 249 implantations. We included 32 patients (24 of them men) who were operated with a BHR HRA during the period April 2004 to March 2007 (42 hips; 31 in men). The mean age of the patients was 59 (26-77) years. These patients underwent magnetic resonance imaging (MRI), serum metal ion measurements, the Oxford hip score questionnaire, and physical examination. The prevalence of ARMD was recorded, and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.7 (2.4-8.8) years. RESULTS: 6 patients had a definite ARMD (involving 9 of the 42 hips). 8 other patients (8 hips) had a probable ARMD. Thus, there was definite or probable ARMD in 17 of the 42 hips. 4 of 42 hips were revised for ARMD. Gender, bilateral metal-on-metal hip replacement and head size were not factors associated with ARMD. INTERPRETATION: We found that HRA with the Birmingham Hip Resurfacing may be more dangerous than previously believed. We advise systematic follow-up of these patients using metal ion levels, MRI/ultrasound, and patient-reported outcome measures.

Adverse reaction to metal debris after ReCap-M2A-Magnum large-diameter-head metal-on-metal total hip arthroplasty.

BACKGROUND AND PURPOSE: The clinical findings of adverse reaction to metal debris (ARMD) following large-diameter-head metal-on-metal total hip arthroplasty (LDH MoM THA) may include periarticular fluid collections, soft tissue masses, and gluteal muscle necrosis. The ReCap-M2a-Magnum LDH MoM THA was the most commonly used hip device at our institution from 2005 to 2012. We assessed the prevalence of and risk factors for ARMD with this device. METHODS: 74 patients (80 hips) had a ReCap-M2a-Magnum LDH MoM THA during the period August 2005 to December 2006. These patients were studied with hip MRI, serum chromium and cobalt ion measurements, the Oxford hip score questionnaire, and by clinical examination. The prevalence of ARMD was recorded and risk factors for ARMD were assessed using logistic regression models. The mean follow-up time was 6.0 (5.5-6.7) years. RESULTS: A revision operation due to ARMD was needed by 3 of 74 patients (3 of 80 hips). 8 additional patients (8 hips) had definite ARMD, but revision was not performed. 29 patients (32 hips) were considered to have a probable or possible ARMD. Altogether, 43 of 80 hips had a definite, probable, or possible ARMD and 34 patients (37 hips) were considered not to have ARMD. In 46 of 78 hips, MRI revealed a soft tissue mass or a collection of fluid (of any size). The symptoms clicking in the hip, local hip swelling, and a feeling of subluxation were associated with ARMD. INTERPRETATION: ARMD is common after ReCap-M2a-Magnum total hip arthroplasty, and we discourage the use of this device. Asymptomatic patients with a small fluid collection on MRI may not need instant revision surgery but must be followed up closely.

Hip resurfacing arthroplasty: short-term survivorship of 4,401 hips from the Finnish Arthroplasty Register.

BACKGROUND AND PURPOSE: Population-based registry data from the Nordic Arthroplasty Register Association (NARA) and from the National Joint Register of England and Wales have revealed that the outcome after hip resurfacing arthroplasty (HRA) is inferior to that of conventional total hip arthroplasty (THA). We analyzed the short-term survival of 4,401 HRAs in the Finnish Arthroplasty Register. METHODS: We compared the revision risk of the 4,401 HRAs from the Register to that of 48,409 THAs performed during the same time period. The median follow-up time was 3.5 (0-9) years for HRAs and 3.9 (0-9) years for THAs. RESULTS: There was no statistically significant difference in revision risk between HRAs and THAs (RR = 0.93, 95% CI: 0.78-1.10). Female patients had about double the revision risk of male patients (RR = 2.0, CI: 1.4-2.7). Hospitals that had performed 100 or more HRA procedures had a lower revision risk than those with less than 100 HRAs (RR = 0.6, CI: 0.4-0.9). Articular Surface Replacement (ASR, DePuy) had inferior outcome with higher revision risk than the Birmingham Hip Resurfacing implant (BHR, Smith & Nephew), the reference implant (RR = 1.8, CI: 1.2-2.7). INTERPRETATION: We found that HRA had comparable short-term survivorship to THA at a nationwide level. Implant design had an influence on revision rates. ASR had higher revision risk. Low hospital procedure volume worsened the outcome of HRA. Female patients had twice the revision risk of male patients.

Corneal flap thickness with the Moria M2 microkeratome and Med-Logics calibrated LASIK blades.

PURPOSE: This study aimed to compare and study potential factors that affect the accuracy of corneal flap thickness created in laser-assisted in situ keratomileusis (LASIK) using the Moria model 2 (M2) head 130 microkeratome with the Med-Logics calibrated LASIK blades Minus 20 (ML -20) and Minus 30 (ML -30). METHODS: Corneal thickness in 200 (164 myopic and 36 hyperopic) eyes (100 patients) was measured by ultrasonic pachymetry preoperatively and intraoperatively after flap cutting. A total of 100 eyes were treated with the ML -20 and 100 with the ML -30. The right eye was operated before the left eye in each patient, using the same blade. In an additional group of 40 eyes, the left eye was operated first. RESULTS: Mean corneal flap thickness using the ML -20 blade for an intended flap thickness of 140 µm was 129.1 µm (standard deviation [SD] 15.6, range 104-165 µm) in right eyes and 111.5 µm (SD 14.5, range 78-144 µm) in left eyes. Mean corneal flap thickness using the ML -30 blade for an intended flap thickness of 130 µm was 127.1 µm (SD 16.6, range 90-168 µm) in right eyes and 109.9 µm (SD 16.8, range 72-149 µm) in left eyes. CONCLUSIONS: Both microkeratome blade types cut thinner flaps than were intended. There was substantial variation in flap thickness. The first flap to be cut with a particular blade was considerably thicker than the second flap cut with the same blade. Based on these data, we recommend the use of disposable single-use microkeratomes rather than these ML blades.

Corneal flap thickness with the Moria M2 single-use head 90 microkeratome.

PURPOSE: To analyse the accuracy of corneal flap thickness created in laser-assisted in situ keratomileusis (LASIK) using the Moria Model 2 (M2) single-use head 90 microkeratome. METHODS: The corneal thickness of 300 (266 myopic and 34 hyperopic) eyes of 150 patients was measured by ultrasonic pachymetry preoperationally and intraoperationally after flap cut. The Moria M2 single-use head 90, intended to create a flap with a thickness of 120 microm, was used in all eyes. The right eye was always operated first and the left eye second, using the same blade. RESULTS: Mean corneal flap thickness was 115.4 microm (standard deviation [SD] 12.5) in the two eyes, 115.7 microm (SD 12.4, range 73-147 microm) in right eyes and 115.1 microm (SD 12.6, range 74-144 microm) in left eyes. Mean horizontal flap diameter was 9.1 mm (SD 0.2) and mean hinge length 4.1 mm (SD 0.1). There were no free flaps, incomplete flaps or flaps with buttonholes in the study. Occasional iron particles were observed in three (1.0%) eyes. CONCLUSIONS: As with most microkeratomes, the single-use head 90 microkeratome cut thinner flaps than were intended. The range of the cuts was relatively wide. However, thin flaps did not increase the rate of flap-related complications. The difference between the first and second eyes was not significant.

Understanding physician acceptance of mobile technology: insights from two telephone interviews in Finland.

This paper sets out to investigate physicians' perceptions and usage regarding a new mobile medical information system in a pilot trial in the Finnish healthcare sector. Two sets of data were gathered in June and October 2003 by telephone interviews. The physicians interviewed had positive perceptions of the mobile system, and started to use it frequently in their work. They showed few negative experiences of using a Nokia Communicator. They favoured using mobile technology as a way to improve spreading medical knowledge. The main contents of the system, the Evidence-Based Medical Guidelines and the Pharmaca Fennica (the pharmacopoeia), were crucial for using the system. Some differences in physicians' behaviour across time were also found. Implications for system improvement are discussed.