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Biomedical subjects

Winston J Warme

Publications and source records attributed to Winston J Warme.

12 recordsLinked to original sources

Industry-funded positive studies not associated with better design or larger size.

Previous studies have associated commercial funding with positive outcomes in orthopaedic research. Those reports, however, failed to account for potential confounding variables that can lead to a disproportion of positive outcomes, including sample size, study design, and study quality. We tested the hypothesis that nonscientific factors (funding source, orthopaedic subspecialty, and geographic region of origin) are associated with positive study outcomes, but not the result of differences in study design, study quality, or sample size. All 747 abstracts presented at the 2004 American Academy of Orthopaedic Surgeons annual meeting underwent blinded analysis using previously published criteria. Studies that received commercial funding were more likely to conclude with positive outcomes. Subspecialty and country of origin were not associated with positive outcomes. Commercially funded studies were not more likely than non-funded studies to be well-designed. When control groups were used, those in commercially funded studies were not larger than those used in nonfunded studies. Our data suggest commercial funding was associated with positive outcomes, but we found no evidence to suggest commercially funded studies were better designed or larger than non-funded studies.

Drug Industry↗

Pectoralis major tendon avulsion from rappelling.

To our knowledge, we are reporting the first case of a pectoralis major tendon avulsion from rappelling. The mechanism of injury in this case differs biomechanically from the commonly associated activity of bench pressing. The patient's initial presentation, course of corrective treatment, and postoperative rehabilitation is discussed in detail. A review of the historical and current literature on pectoralis major tendon injuries is included. The results of current biomechanical studies are discussed in relation to the complex anatomy of the pectoralis major muscle. This report is relevant to individuals involved in rappelling, high-demand athletes, and the surgeons who treat them. Nonoperative management of pectoralis major tendon tears is contrasted with operative repair. The current literature supports operative treatment in high-demand athletes, laborers, and military personnel to allow them to regain full strength and endurance.

Adult↗

External fixator pin tract infection model in the caprine (goat) tibia: a randomized, prospective, blinded study.

Six goats had 2 Schanz pins inserted in each tibia. Twenty-four pins were inoculated with saline or Staphylococcus aureus. Three investigators, blinded to the inoculum, evaluated 23 pins at 14 days. Clinical pin tract infections developed in all inoculated pins and in 5/12 uninoculated pins, Quantitative cultures demonstrated that infections were produced in 10/11 inoculated and in 0/12 uninoculated pins. Prediction of culture status by clinical criterion (P<.01, Fisher Exact Test) had 100% sensitivity and a 58% specificity. The prediction of infection in inoculated sites by culture criterion (P<.001, Fisher Exact Test) had a 91% sensitivity and 100% specificity. A reproducible long bone pin tract infection model was developed that produced clinically and microbiologically evident pin tract infections.

Animals↗

Association between funding source and study outcome in orthopaedic research.

The current report tests the hypotheses that commercial funding, country of origin, and presence of a coinvestigator with training in statistics are related to the likelihood of a published orthopaedic study arriving at a positive conclusion. All articles from the Journal of Bone and Joint Surgery (American), the Journal of Arthroplasty, and the American Journal of Sports Medicine published in 1 year were reviewed. The blinded review process classified each article as to study design and outcome (positive or negative), according to previously published definitions. Commercial funding was significantly associated with a positive outcome; 78.9% of commercially funded studies concluded with a positive outcome, compared with 63.3% of nonfunded studies. The presence of a statistician or epidemiologist as a coinvestigator, and the place of origin of the study were not associated with outcome. Only 21% of published studies were prospective, 3.5% were randomized, and 10.5% stated an experimental hypothesis; these factors were not associated with study outcome. Published studies that received funding from commercial parties were significantly more likely to report a positive outcome than studies that received no such funding. This does not imply the presence of a corrupting or causative influence of industry sponsorship on research outcomes; additional research is needed to determine whether such nonscientific factors actually affect study outcome or likelihood of publication.

Authorship↗

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.

Activities of Daily Living↗

Endogenous cortisol production in response to knee arthroscopy and total knee arthroplasty.

BACKGROUND: There is controversy about whether patients who take exogenous glucocorticoids, such as prednisone, require supplemental (exogenous) glucocorticoids in order to meet the physiological demands of surgery. In this study, we sought to define the magnitude of the surgical stress response in normal patients undergoing major and minor elective orthopaedic surgery. METHODS: A prospective, observational study of thirty patients who had not taken exogenous glucocorticoids and who underwent either elective knee arthroscopy or elective unilateral total knee arthroplasty was performed. Regional anesthesia was used for all patients, and all patients treated with total knee arthroplasty had continuous epidural anesthesia for forty-eight hours after the surgery. The stress response was assessed on the basis of serum and twenty-four-hour urine cortisol levels; comparisons of the urine values were made after correcting for renal function by calculating the cortisol-to-creatinine clearance ratio. RESULTS: Preoperatively, patients undergoing arthroscopy and total knee arthroplasty had similar cortisol-to-creatinine clearance ratios. Patients treated with total knee arthroplasty had a significant (p < 0.001) surgical stress response on the day of the surgery, compared with baseline, whereas patients treated with arthroscopy did not. The mean cortisol-to-creatinine clearance ratio in patients treated with total knee arthroplasty was highest on the day of the surgery and decreased on the third postoperative day. However, on the third postoperative day, the cortisol-to-creatinine clearance ratio still was significantly higher than the baseline value (p < 0.001). Significant differences in the serum cortisol levels also were detected between the patients treated with arthroscopy and those treated with total knee replacement. CONCLUSIONS: Patients undergoing total knee arthroplasty had a significant surgical stress response (a seventeenfold increase in the cortisol-to-creatinine clearance ratio); patients treated with arthroscopy did not. Additional studies, including a prospective trial of patients taking exogenous glucocorticoids, are warranted. Until they are performed, the significantly increased cortisol production observed in non-steroid-dependent patients following total knee arthroplasty leaves open the possibility that steroid-dependent patients undergoing this procedure could benefit from perioperative glucocorticoid supplementation. Since the non-steroid-dependent patients in the present series did not mount a substantial stress response to knee arthroscopy, our results do not support the use of supplemental steroids for that less-invasive procedure.

Arthroplasty, Replacement, Knee↗

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.

Acute-Phase Reaction↗

The circumferential antishock sheet.

Hemorrhage control in patients with pelvic ring disruptions remains problematic. To decrease bleeding, efforts have been made to acutely reduce and stabilize the pelvis. The goals of rapid pelvic reduction and stabilization are restoration of normal pelvic volume, protection of the early clot, and improved patient comfort. The use of military antishock trousers, hip spica casts, external fixators, antishock pelvic clamps, early open reduction/internal fixation, and open packing have been reported in the literature. A simple temporary technique of reduction is reported using a circumferential bed sheet. The sheet is placed between the iliac crests and the greater trochanters, encircling the pelvis. The circumferential sheet provides stabilization for transportation and allows transfemoral angiographic embolization or exploratory laparotomy at the receiving hospital. Definitive fixation can then be accomplished.

Accidents, Traffic↗

Arthroscopic treatment of a transarticular low-velocity gunshot wound using tractoscopy.

An unusual case of a close-range, low-velocity gunshot wound to the knee is presented. Arthroscopic debridement was accomplished using standard anterior portals as well as the existing entry and exit wounds. All bullet fragments were successfully removed from the joint by arthroscopy and tractoscopy. A minimally displaced marginal, lateral tibial plateau fracture was observed and treated with restricted weight bearing and active motion. The patient recovered uneventfully and maintained full knee range of motion and a normal gait.

Aged↗