Anatomic single vs. double-bundle ACL reconstruction: a randomized clinical trial-Part 1: clinical outcomes.

PURPOSE: Compare clinical outcomes of anatomic single-bundle (SB) to anatomic double-bundle (DB) anterior cruciate ligament reconstruction (ACLR). It was hypothesized that anatomic DB ACLR would result in better International Knee Documentation Committee Subjective Knee Form (IKDC-SKF) scores and reduced anterior and rotatory laxity compared to SB ACLR. METHODS: Active individuals between 14 and 50 years of age that presented within 12 months of injury were eligible to participate. Individuals with prior injury or surgery of either knee, greater than a grade 1 concomitant knee ligament injury, or ACL insertion sites less than 14 mm or greater than 18 mm were excluded. Subjects were randomized to undergo SB or DB ACLR with a 10 mm-wide quadriceps tendon autograft harvested with a patellar bone block and were followed for 24 months. The primary outcome measures included the IKDC-SKF and KT-1000 (side to side difference) and pivot shift tests. Other secondary outcomes included measures of sports activity and participation, range of motion (ROM) and re-injury. RESULTS: Enrollment in the study was suspended due to patellar fractures related to harvest of the patellar bone plug. At that time, 57 subjects had been randomized (29 DB) and two-year follow-up was attained from 51 (89.5%). At 24-month follow-up there were no between-group differences detected for the primary outcomes. Twenty-one (77.8%) DB's and 20 (83.3%) SB's reported returning to pre-injury sports 2 years after surgery (n.s) Three subjects (2 DB's, 5.3% of total) sustained a graft rupture and 5 individuals (4 SB's, 8.8% of total) had a subsequent meniscus injury. CONCLUSIONS: Due to the early termination of the study, there were no detectable differences in clinical outcome between anatomic SB and DB ACLR when performed with a quadriceps tendon autograft with a bone block in individuals with ACL insertion sites that range from 14 to 18 mm. LEVEL OF EVIDENCE: Level 2.

Assessing the Patient-Perceived Monetary Value of Patient-Reported Outcome Improvement for Patients With Chronic Knee Conditions.

PURPOSE: The high cost of orthopaedic care has attracted criticism in the current value-based health care environment. The objective of this work was to assess the properties of a willingness to pay (WTP)-based approach to estimate the monetary value that patients place on health improvements in chronic knee conditions following orthopaedic treatment. METHODS: A sample of patients with a chronic knee condition were surveyed between January and May of 2018 at a large orthopaedic practice. Each patient provided their WTP for restoration to ideal knee health and completed the Single Assessment Numerical Evaluation (SANE) to describe their baseline knee state. Average WTP was calculated for the total sample and stratified by income, age, and baseline SANE (for which 0 is the worst and 100 is the best) levels. The patient-perceived monetary value of each unit of SANE improvement was assessed. RESULTS: The study sample included 86 patients seeking orthopaedic care for a chronic knee condition. Mean baseline SANE score was 45.5 (standard deviation: 25.0). Mean WTP to obtain ideal knee function from baseline was $18,704 (standard deviation: $18,040). For the full sample, patients valued a 1-unit improvement in SANE score at $291.1 (ß: 291.1; P<0.05). The amount of money patients were willing to pay to achieve ideal knee function varied with age, income, and baseline knee state. CONCLUSIONS: Patients appear to highly value improvement in chronic knee conditions. Willingness-to-pay survey results appear to track expected variation in patient outcome valuation by income and baseline knee condition and could be a valuable approach to assess value-based care in orthopaedics.

Patient-Reported and Quantitative Outcomes of Anatomic Anterior Cruciate Ligament Reconstruction With Hamstring Tendon Autografts.

BACKGROUND: The pivot-shift test has become more consistent and reliable and is a meaningful outcome measurement after anterior cruciate ligament reconstruction (ACLR). PURPOSE/HYPOTHESIS: The purpose of this investigation was to assess patient-reported outcomes (PROs) and the quantitative pivot shift (QPS) preoperatively, at time zero immediately after anatomic ACLR, and after 24 months as well as the relationship between PROs and the QPS. It was hypothesized that anatomic ACLR would restore rotatory stability measured by the pivot-shift test and that QPS measurements would be positively correlated with PROs. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: The ACL-injured and contralateral uninjured knees from 89 of 107 (83.2%) enrolled patients at 4 international centers were evaluated using a standardized pivot-shift test. Tibial acceleration was assessed with an inertial sensor, and lateral compartment translation was measured using an image analysis system preoperatively, at time zero immediately postoperatively, and at follow-up after 2 years. PROs were assessed at 12 and 24 months postoperatively with the International Knee Documentation Committee (IKDC) subjective knee form, Cincinnati Knee Rating System (CKRS), Marx activity rating scale, and activity of daily living score (ADLS). RESULTS: The mean patient age at surgery was 27 years (range, 15-45 years). A positive pivot shift preoperatively (side-to-side difference in tibial acceleration, 2.6 ± 4.0 m/s2; side-to-side difference in anterior tibial translation, 2.0 ± 2.0 mm) was reduced at time zero postoperatively (side-to-side difference in tibial acceleration, -0.5 ± 1.3 m/s2; side-to-side difference in anterior tibial translation, -0.1 ± 1.0 mm). All PROs improved from preoperatively to final follow-up at 24 months: from 56.5 to 85.5 points for the IKDC (P = .0001), from 28.8 to 32.4 points for the CKRS (P = .04), from 11.2 to 7.9 points for the Marx (P < .0001), and from 75.7 to 91.6 points for the ADLS (P < .0001). Neither preoperative nor time zero postoperative rotatory laxity assessed by the pivot-shift test correlated with PROs at 24-month follow-up. A graft retear was observed in 4 patients (4.5%) within 2 years of follow-up. CONCLUSION: Anatomic ACLR resulted in significantly improved and acceptable PROs at 2-year follow-up and a low failure rate. Anatomic ACLR restored QPS measurements of anterior tibial translation and tibial acceleration to those of the contralateral knee immediately after surgery while still under anesthesia, but there was no correlation between the QPS preoperatively or at time zero after ACLR and PROs at 2-year follow-up.

Anatomic Anterior Cruciate Ligament Reconstruction Using Hamstring Tendons Restores Quantitative Pivot Shift.

BACKGROUND: It is still uncertain how surgical reconstruction of the anterior cruciate ligament (ACL) is able to restore rotatory laxity of the involved joint. The desired amount of restraint applied by the ACL graft, as compared with the healthy knee, has not been fully clarified. PURPOSE: To quantify the ability of single-bundle anatomic ACL reconstruction using hamstring tendons in reducing the pivot-shift phenomenon immediately after surgery under anesthesia. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: An inertial sensor and image analysis were used at 4 international centers to measure tibial acceleration and lateral compartment translation of the knee, respectively. The standardized pivot-shift test was quantified in terms of the side-to-side difference in laxity both preoperatively and postoperatively with the patient under anesthesia. The reduction in both tibial acceleration and lateral compartment translation after surgery and the side-to-side difference were evaluated using the Wilcoxon signed-rank test. Alpha was set at P < .05. RESULTS: A total of 107 patients were recruited for the study, and data were available for 89 patients. There was a statistically significant reduction in quantitative rotatory knee laxity between preoperatively (inertial sensor, 2.55 ± 4.00 m/s2; image analysis, 2.04 ± 2.02 mm) and postoperatively (inertial sensor, -0.54 ± 1.25 m/s2; image analysis, -0.10 ± 1.04 mm) between the involved and healthy joints, as measured by the 2 devices (P < .001 for both). Postoperatively, both devices detected a lower rotatory laxity value in the involved joint compared with the healthy joint (inertial sensor, 2.45 ± 0.89 vs 2.99 ± 1.10 m/s2, respectively [P < .001]; image analysis, 0.99 ± 0.83 vs 1.09 ± 0.92 mm, respectively [P = .38]). CONCLUSION: The data from this study indicated a significant reduction in the pivot shift when compared side to side. Both the inertial sensor and image analysis used for the quantitative assessment of the pivot-shift test could successfully detect restoration of the pivot shift after anatomic single-bundle ACL reconstruction. Future research will examine how pivot-shift control is maintained over time and correlation of the pivot shift with return to full activity in patients with an ACL injury.

Impact of anastomotic leak on outcomes after transhiatal esophagectomy.

BACKGROUND: The development of anastomotic leaks and/or strictures can be associated with considerable morbidity and impairment of quality of life. In the current study, we evaluated the outcomes of patients who developed anastomotic complications after esophagectomy to elucidate the impact of these events on morbidity, mortality, and subsequent need for dilation. METHODS: We analyzed retrospectively the clinical course of 235 patients who underwent transhiatal esophagectomy for cancer from 2001 to 2009. Patients with confirmed anastomotic leaks were identified and classified with the following scale: class 1: Radiographic leak only, no intervention; class 2: leak requiring opening of the wound, cervical and/or percutaneous drainage; class 3: disruption of anastomosis (10-50% circumference) with perianastomotic abscess requiring video-assisted thoracoscopic surgery or thoracotomy; and class 4: gastric tip necrosis with anastomotic separation (>50% circumference). RESULTS: Anastomotic leaks were encountered in 30 patients (13%). Anastomotic leaks were associated with greater morbidity (70% vs 47%; P = .02) and stricture formation (57% vs 19%; P = .0001). Mortality was not different. Increasing leak class was associated with an increased need for postoperative anastomotic dilations (P = .016). CONCLUSION: Anastomotic integrity after esophagectomy has a substantial impact on perioperative course and long-term swallowing. A more formal radiographic and endoscopic leak classification system seems justified.

The use of esophageal transit and gastric emptying studies in the evaluation of patients undergoing laparoscopic fundoplication.

BACKGROUND: Preservation of esophageal and gastric function is a hallmark principle in ensuring optimal surgical outcomes after gastric fundoplication. In this study, we evaluated the impact of fundoplication on esophageal transit and gastric emptying using scintigraphy studies and related these functional findings to symptomatic outcomes. METHODS: A total of 106 consecutive patients (37 women, 69 men) with both preoperative and 6-month postoperative nuclear scintigraphy studies undergoing partial (Toupet) fundoplication at a single institution were analyzed. Primary variables included alterations in esophageal transit and gastric emptying times after fundoplication (1 = rapid; 2 = normal; 3 = mild delay; 4 = severe delay). Symptomatic variables included heartburn, regurgitation, dysphagia, pulmonary symptoms, and bloating. RESULTS: Mean age was 57.2 years. Symptomatic improvement was achieved in 91.5% of patients. Significant reduction of all symptoms (heartburn, regurgitation, pulmonary symptoms, and dysphagia) was noted after fundoplication, except gas bloating (4.7 vs. 20.8%). There were no significant differences in preoperative and postoperative esophageal transit (2.53 vs. 2.52) and gastric emptying (2.13 vs. 2.06) scores after fundoplication. Interestingly, 17% of esophageal transit times and 18% of gastric emptying times improved after fundoplication. However, worsening scores were seen in 16 and 12%, respectively. There was no significant postoperative dysphagia, even in patients with impaired transit times. CONCLUSIONS: Nuclear scintigraphic assessment of esophageal transit and gastric emptying are valuable, user-friendly tools to identify and avoid functional motility problems in the setting of fundoplication. These studies seem to be a reasonable alternative to manometry in assessing esophageal function before surgery in this setting. Postoperative symptoms may be related to objective changes in esophageal transit or gastric emptying. The causes may be iatrogenic in nature or related to vagal denervation with associated changes in esophagogastric compliance. Awareness of these physiologic changes may prompt further technical precautions at the time of surgery to avoid vagal injury and also may facilitate postoperative medical management.