Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.
In this 6-month randomized, multicenter trial, patients with type 1 diabetes were ...assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring.
A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval CI, 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter 3.0 mmol per liter) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group.
In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).
Background:
There are limited data comparing the outcomes of similarly matched patients with a medial meniscus posterior root tear (MMPRT) treated with nonoperative management, partial meniscectomy, ...or repair.
Purpose/Hypothesis:
The purpose was to compare treatment failure, clinical outcome scores, and radiographic findings for a matched cohort of patients who underwent either nonoperative management, partial meniscectomy, or transtibial pull-through repair for an MMPRT. We hypothesized that patients who underwent meniscus root repair will have lower rates of progression to arthroplasty than patients who were treated with nonoperative management or partial meniscectomy.
Study Design:
Cohort study; Level of evidence, 3.
Methods:
Patients who underwent transtibial medial meniscus posterior horn root repair were matched by meniscal laterality, age, sex, and Kellgren-Lawrence (K-L) grades to patients treated nonoperatively or with a partial meniscectomy. Progression to arthroplasty rates, International Knee Documentation Committee and Tegner scores, and radiographic outcomes were analyzed between groups.
Results:
Forty-five patients were included in this study (15 nonoperative, 15 partial meniscectomy, 15 root repair). Progression to arthroplasty demonstrated significant differences among treatment groups at a mean of 74 months (nonoperative, 4/15; partial meniscectomy, 9/15; meniscal repair, 0/15; P = .0003). The meniscus root repair group had significantly less arthritic progression, as measured by change in K-L grade from pre- to postoperatively (nonoperative, 1.0; partial meniscectomy, 1.1; meniscal repair, 0.1; P = .001).
Conclusion:
Meniscus root repair leads to significantly less arthritis progression and subsequent knee arthroplasty compared with nonoperative management and partial meniscectomy in a matched cohort based on patient characteristics.
Purpose To evaluate (1) activity level and knee function, (2) reoperation and failure rates, and (3) risk factors for reoperation and failure of osteochondral autograft transfer (OAT) at minimum ...long-term follow-up. Methods A comprehensive review was performed for long-term outcomes after OAT. Studies reported on activity-based outcomes (Tegner Activity Scale) and clinical outcomes (Lysholm score and International Knee Documentation Committee score). Reoperation and failure rates, as defined by the publishing authors, were recorded for each study. Modified Coleman Methodology Scores were calculated to assess study methodological quality. Results Ten studies with a total of 610 patients with an average age of 27.0 years at the time of surgery and a mean follow-up of 10.2 years were included. The mean defect size was 2.6 cm2 (range, 0.9 to 20.0 cm2 ). The mean duration of symptoms before surgery was 4.8 years. From preoperative to final follow-up, International Knee Documentation Committee scores and Lysholm scores improved significantly by 42.4 (95% confidence interval CI, 31.8 to 53.1, P < .001) and 21.1 (95% CI, 12.2 to 30.0, P < .01), respectively. Tegner score did not improve significantly (0.76, 95% CI, −0.83 to 2.36, P = .35). Overall failure rate was 28% and reoperation rate was 19%. Increased age, previous surgery, and defect size positively correlated with increased risk of failure. Concomitant surgical procedures negatively correlated with failure rate. Conclusions Overall, OAT showed successful outcomes in 72% of patients at long-term follow-up. Increased age, previous surgery, and defect size correlated positively with failure rate, whereas success improved with concomitant surgical procedures. Nonetheless, this systematic review is limited by heterogeneity in a surgical technique, lesion and patient characteristics, and reporting of nonstandardized outcome measures. Level of Evidence Level IV, systematic review of Level I-IV studies.
Background:
The incidence of isolated anterior cruciate ligament (ACL) tears in the general population is not well defined.
Purpose/Hypothesis:
The purpose of this study was to define the ...population-based incidence of ACL tears, describe trends in ACL injuries over time, and evaluate changes in the rate of surgical management. The hypothesis was that the incidence of ACL injury and the rate of subsequent ACL reconstruction increase over time.
Study Design:
Cohort study; Level of evidence, 3.
Methods:
The study population included 1841 individuals who were diagnosed with new-onset, isolated ACL tears (without concomitant ligament injury that required surgery) between January 1, 1990, and December 31, 2010. The complete medical records were reviewed to confirm diagnosis and to extract injury and treatment details. Age- and sex-specific incidence rates were calculated and adjusted to the 2010 US population. Poisson regression analyses were performed to examine incidence trends by age, sex, and calendar period.
Results:
The overall age- and sex-adjusted annual incidence of ACL tears was 68.6 per 100,000 person-years. Incidence was significantly higher in male patients than in females (81.7 vs 55.3 per 100,000, P < .001). The incidence of isolated ACL tears decreased significantly over time in males (P < .001) but remained relatively stable in females. Age-specific patterns differed in male and female patients, with a peak in incidence (241.0 per 100,000) between 19 and 25 years in males and a peak in incidence (227.6 per 100,000) between 14 and 18 years in females. The rate of ACL reconstruction increased significantly over time in all age groups (P < .001).
Conclusion:
With an annual incidence of 68.6 per 100,000 person-years, isolated ACL tears remain a common orthopaedic injury. Differences in age-specific incidence trends in male and female patients may potentially reflect differences in sports participation patterns through the high school and college years. The significant increase in the rate of ACL reconstruction over time may reflect changing surgical indications or an increasing desire among patients to return to high levels of activity after ACL injury.
Although patellar tendon grafts are most commonly used for anterior cruciate ligament reconstruction in the United States, hamstring autograft is most commonly used worldwide. Hamstring advantages ...include easy, quick harvest; low morbidity; ease of rehabilitation (compared with patellar tendon grafts); and relatively less pain. Historically, both the semitendinosus (ST) and gracilis are harvested, but by doubling, tripling, or quadrupling the ST to achieve an 8-mm graft, the gracilis can be spared, resulting in less knee flexion weakness. However, recent research has shown no clinically important difference between ST and ST-gracilis patient outcomes.
Purpose
Medial meniscus posterior root tears (MMPRTs) are a significant source of pain and dysfunction, but little is known about the natural history and outcome and for non-operative management of ...these lesions. The purpose of this study was to evaluate (1) the mid-term clinical and radiographic outcomes of non-operative treatment of MMPRTs and (2) risk factors for worse outcomes.
Methods
A retrospective review was performed for patients with symptomatic, unrepaired MMPRTs and a minimum 2-year follow-up for IKDC and Tegner outcome scores. Baseline and final radiographs were reviewed and graded according to Kellgren–Lawrence scores. Baseline MRIs were reviewed for the presence of meniscal extrusion, subchondral oedema, and insufficiency fractures. Failure was defined as conversion to arthroplasty or severely abnormal patient subjective IKDC score.
Results
Fifty-two patients (21M:31F) with a mean age of 58 ± 10 years were diagnosed with symptomatic MMPRTs clinically and confirmed by MRI and followed for a mean of 62 ± 30 months. Sixteen patients (31 %) underwent total knee arthroplasty at a mean of 30 ± 32 months after diagnosis with higher Kellgren–Lawrence grades associated with increased rates of arthroplasty (
p
= 0.01). Mean IKDC scores for the remaining patients were 61.2 ± 21 with significantly lower scores in females compared to males (75 ± 12 vs. 49 ± 20;
p
= 0.03). Mean Kellgren–Lawrence grades and rates of arthritis progressed over time on radiographs (1.5 ± 0.7 vs. 2.4 ± 1.0;
p
< 0.001 and 78 % vs. 51 %;
p
= 0.01). Overall, 87 % of patients failed non-operative treatment.
Conclusions
Non-operative treatment of medial meniscus posterior horn root tears is associated with poor clinical outcome, worsening arthritis, and a relatively high rate of arthroplasty at 5-year follow-up. Female gender was associated with lower subjective scores and higher rate of arthroplasty. The current study provides a natural history benchmark for clinical outcomes that can be expected in patients with medial meniscus posterior horn root tears undergoing non-operative treatment and helps in counselling patients with these types of injuries.
Level of evidence
IV.
Purpose
The purpose of this study was to determine whether patients with excellent 6-month functional testing after ACL reconstruction had (1) higher risk of subsequent ACL tears, (2) superior knee ...function, and (3) increased activity levels compared to those with delayed clearance for return to sports at midterm follow-up.
Methods
A total of 223 patients underwent primary ACL reconstruction by a single surgeon and had functional and isokinetic testing performed 6 months post-operatively between 1998 and 2005. Of the 223 patients, 52 (23 %) made the excellent group and were allowed return to sport at 6 months, and the remaining 171 (77 %) constituted the delayed group. Rate of ACL graft tear and native contralateral ACL tear was compared between groups. In addition, IKDC and Tegner scores were compared at a mean 4-year follow-up.
Results
The graft rupture rate was similar in the excellent group (3.8 %,
n
= 2) compared to the delayed group (4.7 %,
n
= 8;
p
= 0.30). However, there was a higher rate of contralateral ACL tear in the excellent group (15.4 %,
n
= 8 vs. 5.3 %,
n
= 9;
p
= 0.003). The excellent 6-month group had superior IKDC scores (94.3 ± 6.4 vs. 90.9 ± 9.7;
p
= 0.04) and Tegner scores (6.6 ± 1.8 vs. 5.7 ± 1.6;
p
= 0.01).
Conclusion
Patients with an excellent performance on their isokinetic strength and functional testing at 6 months after ACL reconstruction have superior knee function and higher activity levels at midterm follow-up. However, these patients appear to be at greater risk of contralateral ACL injury, which may be related to their increased activity level. When isokinetic and functional testing is used for return-to-sport decisions, physicians should caution patients about the risk of contralateral ACL injury for high performing patients.
Level of evidence
Retrospective Review with Control, Level III.
Although isolated posterior cruciate ligament (PCL) injuries often can be treated successfully without surgical intervention, in the setting of persistent instability or multiligamentous knee injury, ...PCL reconstruction is indicated. PCL reconstructions often have resulted in persistent postoperative laxity. Recent research suggests there may be a role for suture tape–augmented grafts, which have demonstrated decreased clinical and radiographic laxity as well as improved rates of return to previous level of activity, as compared with PCL reconstruction alone. Several biomechanical studies also have supported the use of suture tape augmentation in PCL reconstruction, and the use of suture tape augmentation or internal bracing and ligament surgery is gaining widespread popularity. These ultrahigh molecular weight polyethylene/polyester suture tapes have been shown to be safe and effective. We may be at the point at which the evidence supports the use of suture tape augmentation of PCL reconstruction.
Background:
Femoroacetabular impingement (FAI) is a well-known cause of hip pain in adolescents and young adults. However, the incidence in the general population has not been clearly defined.
...Purpose:
To (1) define the population-based incidence of diagnosis of FAI in patients with hip pain, (2) report the trends in diagnosis of FAI over time, and (3) determine the changes in the rate and type of surgical management over time.
Study Design:
Cohort study; Level of evidence, 3.
Methods:
A geographic database was used to identify patients who were 14 to 50 years old with hip pain between the years 2000 and 2016. Chart and radiographic review was performed to determine which patients had FAI. To be included, patients had to have a triad of clinical symptoms, physical examination signs, and imaging findings consistent with FAI. Medical records were reviewed to obtain demographic information, clinical history, physical examination findings, imaging details, and treatment details. Statistical analysis determined the overall age- and sex-adjusted annual incidence of FAI diagnosis and trends over time.
Results:
There were 1893 patients evaluated with hip pain, and 716 (38%; 813 hips) had diagnosed FAI. The mean ± SD age was 27.2 ± 8.4 years, and 67% were female. The incidence of FAI diagnosis was 54.4 per 100,000 person-years. Female patients had a higher incidence than male patients (73.2 vs 36.1 per 100,000 person-years; P < .01). Incidence of FAI diagnosis were higher from 2010 to 2016 (72.6 per 100,000 person-years; P < .01) as compared with 2005 to 2009 (45.3) and 2000 to 2004 (40.3). Hip arthroscopy, surgical hip dislocation, and periacetabular osteotomy utilization increased from the 2000-2004 to 2010-2016 periods, respectively: 1 (1%) to 160 (20%; P = .04), 2 (1%) to 37 (5%; P = .01), and 1 (1%) to 22 (3%; P = .58).
Conclusion:
The overall incidence of FAI diagnosis was 54.4 per 100,000 person-years, and it consistently increased between 2000 and 2016. Female patients had a higher incidence than male patients. The utilization of joint preservation operations, including hip arthroscopy, surgical hip dislocation, and anteverting periacetabular osteotomy, increased over time.
Objective
To determine the 5‐year outcome of treatment for meniscal tear in osteoarthritis.
Methods
We examined 5‐year follow‐up data from the Meniscal Tear in Osteoarthritis Research trial (METEOR) ...of physical therapy versus arthroscopic partial meniscectomy. We performed primary intent‐to‐treat (ITT) and secondary as‐treated analyses. The primary outcome measure was the Knee Injury and Osteoarthritis Outcome Score (KOOS) pain scale; total knee replacement (TKR) was a secondary outcome measure. We used piecewise linear mixed models to describe change in KOOS pain. We calculated 5‐year cumulative TKR incidence and used a Cox model to estimate hazard ratios (HRs) for TKR, with 95% confidence intervals (95% CIs).
Results
Three hundred fifty‐one participants were randomized. In the ITT analysis, the KOOS pain scores were ~46 (scale of 0 no pain to 100 most pain) at baseline in both groups. Pain scores improved substantially in both groups over the first 3 months, continued to improve through the next 24 months (to ~18 in each group), and were stable at 24–60 months. Results of the as‐treated analyses of the KOOS pain score were similar. Twenty‐five participants (7.1% 95% CI 4.4–9.8%) underwent TKR over 5 years. In the ITT model, the HR for TKR was 2.0 (95% CI 0.8–4.9) for subjects randomized to the arthroscopic partial meniscectomy group, compared to those randomized to the physical therapy group. In the as‐treated analysis, the HR for TKR was 4.9 (95% CI 1.1–20.9) for subjects ultimately treated with arthroscopic partial meniscectomy, compared to those treated nonoperatively.
Conclusion
Pain improved considerably in both groups over 60 months. While ITT analysis revealed no statistically significant differences following TKR, greater frequency of TKR in those undergoing arthroscopic partial meniscectomy merits further study.
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