Seth S. Leopold

Arthroscopic compared with open repairs for recurrent anterior shoulder instability. A systematic review and meta-analysis of the literature.

BACKGROUND Both arthroscopic and open surgical repairs are utilized for the management of anterior glenohumeral instability. To determine the evidence supporting the relative effectiveness of these two approaches, we conducted a rigorous and comprehensive analysis of all reports comparing arthroscopic and open repairs. METHODS A systematic analysis of eighteen published or presented studies was performed to determine if there were significant differences between the two approaches with regard to recurrence (recurrent dislocation, subluxation, and/or apprehension and/or a reoperation for instability), return to work and/or sports, and Rowe scores. We also performed subgroup analysis to determine if the quality of the study or the arthroscopic technique influenced the results. RESULTS We identified four randomized controlled trials, ten controlled clinical trials, and four other comparative studies. Results were influenced both by the quality of the study and by the arthroscopic technique. Meta-analysis revealed that, compared with open methods, arthroscopic repairs were associated with significantly higher risks of recurrent instability (p < 0.00001, relative risk = 2.37, 95% confidence interval = 1.66 to 3.38), recurrent dislocation (p < 0.0001, relative risk = 2.74, 95% confidence interval = 1.75 to 4.28), and a reoperation (p = 0.002, relative risk = 2.32, 95% confidence interval = 1.35 to 3.99). When considered alone, arthroscopic suture anchor techniques were associated with significantly higher risks of recurrent instability (p = 0.01, relative risk = 2.25, 95% confidence interval = 1.21 to 4.17) and recurrent dislocation (p = 0.004, relative risk = 2.57, 95% confidence interval = 1.35 to 4.92) than were open methods. Arthroscopic approaches were also less effective than open methods with regard to enabling patients to return to work and/or sports (p = 0.03, relative risk = 0.87, 95% confidence interval = 0.77 to 0.99). On the other hand, analysis of the randomized clinical trials indicated that arthroscopic repairs were associated with higher Rowe scores (p = 0.002, standardized mean difference = 0.43, 95% confidence interval = 0.16 to 0.70) than were open methods. Similarly, analysis of the arthroscopic suture anchor techniques alone showed the Rowe scores to be higher (p = 0.04, standardized mean difference = 0.29, 95% confidence interval = 0.01 to 0.56) than those associated with open methods. CONCLUSIONS The available evidence indicates that arthroscopic approaches are not as effective as open approaches in preventing recurrent instability or enabling patients to return to work. Arthroscopic approaches resulted in better function as reflected by the Rowe scores in the randomized clinical trials. The study design and the arthroscopic technique had substantial effects on the results of the analysis.

Minimally invasive total knee arthroplasty compared with traditional total knee arthroplasty. Assessment of the learning curve and the postoperative recuperative period.

BACKGROUND There is disagreement about whether so-called minimally invasive approaches result in faster recovery following total knee arthroplasty. It is also unknown whether patients are exposed to excess risk during the surgeons learning curve. We hypothesized that a minimally invasive quadriceps-sparing approach to total knee arthroplasty would allow earlier clinical recovery but would require longer operative times and compromise component alignment during the learning period compared with a traditional medial parapatellar approach. METHODS The first 100 minimally invasive total knee arthroplasties done by a single high-volume arthroplasty surgeon were compared with his previous fifty procedures performed through a medial parapatellar approach, with respect to operative times, implant alignment, and clinical outcomes. Radiographic end points and operative times for the minimally invasive group were evaluated against increasing surgical experience, in order to characterize the learning curve. RESULTS Overall, the minimally invasive approach took significantly longer to perform, on the average, than a medial parapatellar approach (86.3 and 78.9 minutes, respectively; p=0.01); this was the result of especially long operative times in the first twenty-five patients in the minimally invasive group (mean, 102.5 minutes). After the first twenty-five minimally invasive operations, no significant difference in the operative times was detected between the groups. The first twenty-five minimally invasive procedures had significantly less patellar resection accuracy (p<0.001) and significantly more patellar tilt than the last twenty-five (p=0.006). Other end points for implant alignment, including the frequency of radiographic outliers, were not different between the minimally invasive and traditional groups. The patients who had the minimally invasive approach demonstrated significantly better clinical outcomes with respect to the length of hospital stay (p<0.0001), need for inpatient rehabilitation after discharge (p<0.001), narcotic usage at two and six weeks postoperatively (p=0.001 and p=0.01, respectively), and the need for assistive devices to walk at two weeks postoperatively (p=0.025). CONCLUSIONS A quadriceps-sparing minimally invasive approach seems to facilitate recovery, but a substantial learning curve (fifty procedures in the hands of a high-volume arthroplasty surgeon) may be required. If this experience is typical, the learning curve may be unacceptably long for a low-volume arthroplasty surgeon.

Commercially Funded and United States-Based Research Is More Likely to Be Published; Good-Quality Studies with Negative Outcomes Are Not

BACKGROUND Prior studies implying associations between receipt of commercial funding and positive (significant and/or pro-industry) research outcomes have analyzed only published papers, which is an insufficiently robust approach for assessing publication bias. In this study, we tested the following hypotheses regarding orthopaedic manuscripts submitted for review: (1) nonscientific variables, including receipt of commercial funding, affect the likelihood that a peer-reviewed submission will conclude with a report of a positive study outcome, and (2) positive outcomes and other, nonscientific variables are associated with acceptance for publication. METHODS All manuscripts about hip or knee arthroplasty that were submitted to The Journal of Bone and Joint Surgery, American Volume, over seventeen months were evaluated to determine the study design, quality, and outcome. Analyses were carried out to identify associations between scientific factors (sample size, study quality, and level of evidence) and study outcome as well as between non-scientific factors (funding source and country of origin) and study outcome. Analyses were also performed to determine whether outcome, scientific factors, or nonscientific variables were associated with acceptance for publication. RESULTS Two hundred and nine manuscripts were reviewed. Commercial funding was not found to be associated with a positive study outcome (p = 0.668). Studies with a positive outcome were no more likely to be published than were those with a negative outcome (p = 0.410). Studies with a negative outcome were of higher quality (p = 0.003) and included larger sample sizes (p = 0.05). Commercially funded (p = 0.027) and United States-based (p = 0.020) studies were more likely to be published, even though those studies were not associated with higher quality, larger sample sizes, or lower levels of evidence (p = 0.24 to 0.79). CONCLUSIONS Commercially funded studies submitted for review were not more likely to conclude with a positive outcome than were nonfunded studies, and studies with a positive outcome were no more likely to be published than were studies with a negative outcome. These findings contradict those of most previous analyses of published (rather than submitted) research. Commercial funding and the country of origin predict publication following peer review beyond what would be expected on the basis of study quality. Studies with a negative outcome, although seemingly superior in quality, fared no better than studies with a positive outcome in the peer-review process; this may result in inflation of apparent treatment effects when the published literature is subjected to meta-analysis.

Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment

Background: Intra-articular knee injections with hylan GF-20 (Synvisc) have been shown to provide temporary relief of osteoarthritic symptoms. Several studies have suggested that repeated courses of treatment with this product may be administered without an increase in the likelihood of an adverse reaction. The present study was performed to test the hypothesis that the likelihood of a painful reaction to hylan GF-20 does not increase in patients who receive more than one course of treatment.Methods: The records of all patients who had received more than one course of treatment with hylan GF-20 were compared with a group of patients who had received only one course of treatment during the same fifteen-month period at a single center. The single-course group was prospectively enrolled and followed, as part of an ongoing randomized trial. The two groups were compared with respect to several demographic and clinical parameters as well as with respect to the frequency of painful acute local reactions following injections of hylan GF-20.Results: Local reactions to hylan GF-20 occurred significantly more often in patients who had received more than one course of treatment than they did in patients who had received only a single course of treatment; the reactions occurred in four (21%) of nineteen patients in the former group and in one (2%) of the forty-two patients in the latter (p = 0.029). All of the reactions were severe enough to cause the patient to seek unscheduled care. Following corticosteroid injection, the reactions abated without apparent sequelae. With the numbers available, no significant differences were detected between the multiple-course and single-course groups in terms of age, gender, body-mass index, or severity or bilaterality of the disease.Conclusions: The present study suggests that it may be reasonable to counsel patients who have been treated with a course of hylan GF-20 and who desire an additional course that the likelihood of a painful acute local reaction to the medication appears to be increased. Additional study of the frequency of acute local reactions following repeated courses of hylan GF-20 and investigation of the mechanisms of those reactions are warranted.

Corticosteroid compared with hyaluronic acid injections for the treatment of osteoarthritis of the knee a prospective, randomized trial

Background: Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis, little research involving a comparison of the two interventions has been done. We tested the hypothesis that there are no significant differences between Hylan G-F 20 (Synvisc) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate (Celestone Soluspan) in terms of pain relief or improvement in function, as determined by validated scoring instruments. Methods: One hundred patients with knee osteoarthritis were randomized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid, and they were followed for six months. The patients treated with Hylan G-F 20 received one course of three weekly injections. The patients treated with the corticosteroid received one injection at the time of enrollment in the study, and they could request one more injection any time during the study. An independent, blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a modification of the Knee Society rating system, and the visual analog pain scale. Results: Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores (a median decrease from 55 to 40 points and from 54 to 44 points, respectively; p < 0.01 for both). The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid (median, 58 to 70 points; p = 0.06) or for those who received Hylan G-F 20 (median, 58 to 68 points; p = 0.15). The scores on the visual analog scale improved for patients receiving Hylan G-F 20 (median, 70 to 52 mm; p < 0.01) but not for the patients who received the corticosteroid (median, 64 to 52 mm; p = 0.28). However, no significant differences between the two treatment groups were found with respect to the WOMAC, Knee Society system, or visual analog scale results. Women demonstrated a significant improvement in only one of the six possible outcome-treatment combinations (the WOMAC scale), whereas men demonstrated significant improvements in five of the six outcomes (all measures except the Knee Society rating system). Conclusions: No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up. Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales. Such significant gender-related differences warrant further investigation. Level of Evidence: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]). See Instructions to Authors for a complete description of levels of evidence.

Impaction allografting with cement for revision of the femoral component. A minimum four-year follow-up study with use of a precoated femoral stem.

BACKGROUND Cancellous impaction allografting with cement for revision of the femoral component has conventionally been performed with a polished, tapered implant, which was designed to allow subsidence of the component. However, subsidence has been associated with pain in the thigh, dislocation of the hip, and revision of the component. This prospective study tested the hypothesis that good clinical results can be achieved--without subsidence of the component--with use of impaction allografting and a precoated, collared, straight stem for difficult femoral revisions. METHODS Twenty-nine patients had revision of the femoral component with use of impaction allografting with cement and a Harris Precoat stem. Impaction allografting was performed when loss of metaphyseal and diaphyseal bone precluded revision with more straightforward techniques or when reconstitution of bone was considered a specific goal of the reconstruction (as was sometimes the case with revision of the component in younger patients). The patients were followed prospectively and were evaluated with use of the Harris hip score and serial radiographs. The patients were followed for a minimum of four years (mean, sixty-three months), except for four who died. RESULTS Four patients died before the minimum four-year follow-up period had elapsed; all four had the prosthesis in place at the time of death. The Harris hip scores improved from a preoperative mean of 54 points (poor) (range, 21 to 91 points) to a mean of 87 points (good) (range, 41 to 100 points) at the time of the most recent follow-up. Kaplan-Meier survivorship analysis, with aseptic loosening as the end point, was 92 percent (95 percent confidence interval, 82 to 100 percent) at six years; one additional hip failed because of a hematogenous infection at seventy-three months postoperatively, for an overall failure rate of 12 percent (three of twenty-five patients) at the time of the most recent follow-up. Two hips needed a repeat revision; one was revised because of subsidence of the stem with recurrent osteolysis and the other, in a patient who had hemodialysis, because of late sepsis. A third femoral component subsided and failed but was not revised. Radiographic evidence of bone-stock reconstitution was observed in six (29 percent) of the twenty-one patients for whom radiographs were available. As in other series of patients managed with impaction allografting, the complication rate was high; excluding the revisions, three reoperations were performed, and six patients had either intraoperative femoral fracture or perforation necessitating cerclage wiring or cortical strut allografting and cerclage wiring at the time of the procedure. There were six nonunions in eighteen patients who had been operated on with a transtrochanteric approach. CONCLUSIONS Difficult revisions of the femoral component with use of impaction allografting and a precoated stem provided satisfactory clinical and radiographic results at the time of intermediate-term follow-up. However, the high rate of complications in our series led us to refine our indications for the procedure.

Safety and efficacy of intraarticular hip injection using anatomic landmarks.

This study tests the hypotheses that the hip can be injected safely and reliably, using anatomic landmarks, without fluoroscopic guidance. Fifteen human cadavers (30 hips) were injected, each receiving one anterior hip injection and one lateral hip injection with methylene blue dye. Anatomic dissections were done on all 30 specimens to determine the rate of success and the proximity of the needle to the neurovascular structures about the hip with each approach. Neither the anterior nor the lateral injection approach, using published techniques based on anatomic landmarks, was sufficiently reliable to recommend for clinical use without radiographic guidance; the anterior approach was successful in only 60% of injections, and the lateral technique was successful in 80% of injections. In addition, the anterior approach, which is recommended in more reference works than any other approach, resulted in significantly more risk to the femoral nerve than did the lateral approach. The needle pierced or contacted the femoral nerve in 27% of anterior injections and was within 5 mm of the femoral nerve in 60% of anterior attempts. The anterior injection approach also resulted in needle placements significantly closer to the femoral artery and the lateral femoral cutaneous nerve than did the lateral approach. Using the lateral approach, the needle was never within 25 mm of any neurovascular structure in any injection. Some form of radiographic or sonographic guidance is recommended for needle placement during hip injections and aspirations; the lateral approach for needle placement seems safer than the anterior approach, with respect to the possibility of neurovascular injury.

Comparison of one and two-stage revision of total hip arthroplasty complicated by infection: a Markov expected-utility decision analysis.

BACKGROUND Two-stage revisions of total hip arthroplasties complicated by chronic infection result in reinfection rates that are lower than those following single-stage revisions but may also result in increased surgical morbidity. Using a decision analysis, we compared single-stage and two-stage revisions to determine which treatment modality resulted in greater quality-adjusted life years (QALYs). METHODS A review of the literature on the treatment of patients with an infection at the site of a total hip arthroplasty provided probabilities; utility values for common postoperative health states were determined in a previously published study. With these data, we conducted a Markov cohort simulation decision analysis. Sensitivity analysis validated the model, and comparisons were made in terms of QALYs. RESULTS The twelve-month model favored direct-exchange revision over the two-stage approach, regardless of whether surgeon or patient-derived utilities were used (0.945 versus 0.896 and 0.897 versus 0.861 QALYs for the patient and surgeon models, respectively). Similar results were observed in a lifetime model with a ten-year life expectancy (7.853 versus 7.771, and 7.438 versus 7.362 QALYs, respectively). The findings were found to be robust in sensitivity analyses in which clinically relevant ranges of input variables were used. CONCLUSIONS This analysis favored the direct-exchange arthroplasty over the two-stage approach. This study should be considered hypothesis-generating for future randomized controlled trials in which, ideally, health end points will be considered in addition to the eradication of infection.

Constraint in primary total knee arthroplasty.

Abstract Instability is an important cause of failure following total knee arthroplasty. Increasing component constraint may reduce instability, but doing so also can cause increased forces to be transmitted to fixation and implant interfaces, which may lead to premature aseptic loosening. Constraint is defined as the effect of the elements of knee implant design that provides the stability needed to counteract forces about the knee after arthroplasty in the presence of a deficient soft‐tissue envelope. Determining the amount of constraint necessary can be challenging. Most primary total knee arthroplasties are performed for knees without substantial deformity or the need for difficult ligament balancing; in these cases, either a posterior‐stabilized or a posterior cruciate‐retaining design is appropriate. In certain situations, such as patients with prior patellectomies, rheumatoid arthritis, or substantial preoperative deformities, a posterior‐stabilized knee may be favored. With their large posts, varus‐valgus constrained implants typically are reserved for patients with substantial coronal plane instability, which is difficult to balance with a posterior‐stabilized or cruciate‐retaining implant alone. Rotatinghinge knee implants usually are recommended for patients with severe deformity or instability that cannot be managed with a varus‐valgus implant.

Corticosteroid compared with hyaluronic acid injections for the treatment of osteoarthritis of the knee

Background: Although both corticosteroid and hyaluronic acid injections are widely used to palliate the symptoms of knee osteoarthritis, little research involving a comparison of the two interventions has been done. We tested the hypothesis that there are no significant differences between Hylan G-F 20 (Synvisc) and the corticosteroid betamethasone sodium phosphate-betamethasone acetate (Celestone Soluspan) in terms of pain relief or improvement in function, as determined by validated scoring instruments. Methods: One hundred patients with knee osteoarthritis were randomized to receive intra-articular injection of either Hylan G-F 20 or the corticosteroid, and they were followed for six months. The patients treated with Hylan G-F 20 received one course of three weekly injections. The patients treated with the corticosteroid received one injection at the time of enrollment in the study, and they could request one more injection any time during the study. An independent, blinded evaluator assessed the patients with the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), a modification of the Knee Society rating system, and the visual analog pain scale. Results: Both the group treated with the corticosteroid and the group treated with Hylan G-F 20 demonstrated improvements from baseline WOMAC scores (a median decrease from 55 to 40 points and from 54 to 44 points, respectively; p < 0.01 for both). The scores according to the Knee Society system did not significantly improve for the patients who received the corticosteroid (median, 58 to 70 points; p = 0.06) or for those who received Hylan G-F 20 (median, 58 to 68 points; p = 0.15). The scores on the visual analog scale improved for patients receiving Hylan G-F 20 (median, 70 to 52 mm; p < 0.01) but not for the patients who received the corticosteroid (median, 64 to 52 mm; p = 0.28). However, no significant differences between the two treatment groups were found with respect to the WOMAC, Knee Society system, or visual analog scale results. Women demonstrated a significant improvement in only one of the six possible outcome-treatment combinations (the WOMAC scale), whereas men demonstrated significant improvements in five of the six outcomes (all measures except the Knee Society rating system). Conclusions: No differences were detected between patients treated with intra-articular injections of Hylan G-F 20 and those treated with the corticosteroid with respect to pain relief or function at six months of follow-up. Women demonstrated significantly less response to treatment than men did for both treatments on all three outcome scales. Such significant gender-related differences warrant further investigation. Level of Evidence: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]). See Instructions to Authors for a complete description of levels of evidence.