Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Evidence-based postoperative pain management in nursing: is a randomized-controlled trial the most appropriate design? Lumbar spinal stenosis: conservative or surgical management?: A prospective 10-year study. The management of acute acromioclavicular dislocation. A randomised prospective controlled trial. Comparison between single-and double-bundle anterior cruciate ligament reconstruction: a prospective, randomized, single-blinded clinical trial. [Therapy of fresh fibular ligament ruptures]. Reconstruction of the ACL with a semitendinosus tendon graft: a prospective randomized single blinded comparison of double-bundle versus single-bundle technique in male athletes. Conservative versus surgical treatment for repair of the medial patellofemoral ligament in acute dislocations of the patella. Arthroscopically assisted ACL reconstruction. Is a drain necessary?
A variety of graft sources have been used for ACL reconstruction to improve functions and kinematics in ACL deficient knees. The two most commonly used autogenous grafts are the central third of the patellar tendon and the hamstring tendon constructs. The choice of different grafts and different construct influence the final clinical outcome of ACL reconstruction. The 3 groups, of 25 patients each, were generated by choosing the technique (PT tendon, 4 strand hamstring, and single hamstring plus extraarticular plasty) to utilize and followed for 5 years, with an alternate systematic sampling. Our comparison has shown significant kneeling pain in the patellar tendon with respect to the groups with hamstrings techniques. Single hamstring plus extraarticular plasty achieved subjective score significantly higher with respect to the other two groups as well as for the time to resume sport. The study confirms that patellar tendon and hamstring can be equivalent options for ACL reconstruction. This study demonstrated that a superior outcome as far as subjective clinical findings were concerned, was obtained in group III. Patients in the latter group were also able to return to sports sooner than those in the bone-patellar tendon graft group and the four-strand hamstring group. There is an increasing drive to make nursing care evidence-based. High quality evidence from systematic reviews relevant to postoperative pain relief exists, yet pain after surgery remains poorly controlled for many patients. This study aimed to assess whether implementing evidence-based pain management improved postoperative pain outcomes. Pain on a 0-10 scale was the primary outcome and analgesic consumption a secondary outcome. A baseline audit was undertaken on four surgical wards to establish whether there was a need for the study. A randomized-controlled trial was then designed to assess the effects of implementing an evidence-based approach to postoperative pain management. The four wards were randomized to receive the intervention or act as a control. Outcomes were assessed 3 months after the intervention on both intervention and control wards. The intervention (implementation of an oral analgesic algorithm derived from systematic reviews) was then implemented on the control wards and outcomes reassessed after 3 months on the control wards. The intervention was designed using an evidence-based approach to effective implementation. Four interactive sessions covered: (1) detailed feedback of baseline data and discussion (utilizing audit and feedback), (2) why systematic reviews, analgesic league tables and choice of drugs to develop an analgesic algorithm (see Figure 1), (3) principles of evidence based health care (EBHC), including critical appraisal and (4) facilitation and change workshop. The findings revealed no significant differences in pain level or drug use between the intervention and control wards. However, the control wards also changed during the control period. Possible explanations for this are discussed. When looking at changes compared with baseline, both intervention and control wards increased their use of algorithm drugs and reduced use of non-algorithm drugs during the study. No effects were found on pain in the intervention wards. Pain ratings at rest since surgery, on movement since surgery and worst pain on movement were significantly reduced compared with baseline in the control wards. Although there are many pressures to utilize a randomized-controlled trial study design in the culture of evidence-based health care, there will be times, especially when implementing complex changes in practice that other types of design should be considered. A cohort of 100 patients with symptomatic lumbar spinal stenosis, characterized in a previous article, were given surgical or conservative treatment and followed for 10 years.
                To identify the short- and long-term results after surgical and conservative treatment, and to determine whether clinical or radiologic predictors for the treatment result can be defined.
                Surgical decompression has been considered the rational treatment. However, clinical experience indicates that many patients do well with conservative treatment.
                In this study, 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment, whereas 31 patients were randomized between the conservative (n = 18) and surgical (n = 13) treatment groups. Pain was decisive for the choice of treatment group. All patients were observed for 10 years by clinical evaluation and questionnaires. The results, evaluated by patient and physician, were rated as excellent, fair, unchanged, or worse.
                After a period of 3 months, relief of pain had occurred in most patients. Some had relief earlier, whereas for others it took 1 year. After a period of 4 years, excellent or fair results were found in half of the patients selected for conservative treatment, and in four fifths of the patients selected for surgery. Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months (median, 3.5 months). The treatment result of delayed surgery was essentially similar to that of the initial group. The treatment result for the patients randomized for surgical treatment was considerably better than for the patients randomized for conservative treatment. Clinically significant deterioration of symptoms during the final 6 years of the follow-up period was not observed. Patients with multilevel afflictions, surgically treated or not, did not have a poorer outcome than those with single-level afflictions. Clinical or radiologic predictors for the final outcome were not found. There were no dropouts, except for 14 deaths.
                The outcome was most favorable for surgical treatment. However, an initial conservative approach seems advisable for many patients because those with an unsatisfactory result can be treated surgically later with a good outcome. In a prospective study, 60 patients with acute acromioclavicular dislocation were randomly allocated to treatment with a broad arm sling or to reduction and fixation with a coracoclavicular screw. Of these 54 were followed for four years. Conservatively-treated patients regained movement significantly more quickly and fully, returned to work and sport earlier and had fewer unsatisfactory results than those having early operation. For severe dislocations, with acromioclavicular displacement of 2 cm or more, early surgery produced better results. Conservative management is best for most acute dislocations, but younger patients with severe displacement may benefit from early reduction and stabilisation. Double-bundle ACL reconstruction popularity is increasing with the aim to reproduce native ACL anatomy and improve ACL reconstruction outcome. However, to date, only a few randomized clinical studies have been published.
                The aim of this study was to prospectively compare the clinical results of single- and double-bundle ACL reconstruction.
                Randomized controlled clinical trial; Level of evidence, 1.
                Seventy patients with a chronic unilateral ACL rupture who underwent arthroscopically assisted ACL reconstruction using a hamstring graft were randomized to receive a single- (SB) or double-bundle (DB) reconstruction. Both groups were comparable with regard to preoperative data. A double-incision surgical technique was adopted in both groups. The graft was fixed by looping the hamstring tendons around a bony (DB) or a metallic (SB) bridge on the tibial side and with interference screws reinforced with a staple on the femur. The same rehabilitation protocol was adopted. Outcome assessment was performed by a blinded, independent observer using the visual analog scale (VAS) score, the new International Knee Documentation Committee (IKDC) form, the Knee Injury and Osteoarthritis Outcome Score (KOOS), and KT-1000 arthrometer evaluation.
                All the patients reached a minimum follow-up of 2 years. No differences between the 2 groups were observed in terms of KOOS and IKDC subjective score. A statistically significant difference in favor of the DB group was found with the VAS (P < .03). The objective IKDC final scores showed statistically significantly more "normal knees" in the DB group than in the SB group (P = .03). There was 1 stability failure in the DB group and 3 in the SB group. The KT-1000 arthrometer data showed a statistically significant decrease in the average anterior tibial translation in the DB group (1.2 mm DB vs 2.1 mm SB; P < .03). The incidence of a residual pivot-shift glide was 14% in DB and 26% in SB (P = .08).
                In the 2-year minimum follow-up, DB ACL reconstructions showed better VAS, anterior knee laxity, and final objective IKDC scores than SB. However, longer follow-up and accurate instrumented in vivo rotational stability assessment are needed. In a prospective, random study carried out at the Casualty Clinic of the University Hospital of Hannover from 15 April 1986 to 31 July 1986, 200 patients were randomly selected from four treatment groups, according to treatment: operative-immobilized (group A, n = 52), operative-functional (group B, n = 50), conservative-immobilized (group C, n = 48) and conservative-functional (group D, n = 50). Follow-up examinations were made in 92.5% of patients after 3 months and 64% after 12 months. At the 3-month and 1-year follow-ups, no statistically significant differences were found in the total evaluation (100-point checklist) Moderately significant instability (6 degrees -10 degrees talar tilt and 6-10 mm anterior talar dislocation) in the conservative groups C and D was observed only in the clinical-radiological instability test. This statistically significant difference is, however, only evident in stress tenographically confirmed dual-ligament lesions. No functional physiological differences can be found after 12 months; on average, the period of incapacitation is 3 weeks shorter than with primary functional treatment, but so far there are no long-term results. Until late results are available, we conclude that conservative treatment, even for professional athletes, can be recommended as the procedure most free of risk and most economical; if at all, operative therapy should only be carried out when the instability is very serious. Anterior cruciate ligament (ACL) reconstruction in double-bundle technique is advocated to more closely restore the anatomy and function of the native ligament than conventional single-bundle technique. But up to now there are only a few clinical investigations comparing both techniques in a prospective manner. We hypothesized that double-bundle ACL reconstruction reveals superior clinical and subjective results compared to single-bundle technique in a high-demand collective. A total of 50 male patients (mean age 29.4 years) were prospectively randomized consecutively into one of the two reconstruction techniques. Group 1 (SB) underwent a 4-stranded single-bundle reconstruction with a ST graft in femoral position at 10:00 and 02:00 o'clock, respectively. In group 2 (DB), reconstruction was performed by using a 2-stranded ST graft with double-bundle, four tunnel technique. Before surgery and at a 2 year follow-up (range 23-25 months) patients were evaluated by the same blinded observer. There was no significant difference in the side-to-side anterior laxity-measurement with the KT-1000 between both groups. As evaluated by the pivot shift, no significant correlation could be noted (Fisher exact test P = 0.098) between rotational stability and any of the both reconstruction techniques. However, the anterior and rotational stability improved significantly at 2-year follow-up compared to preoperatively (P = 0.003) in both groups. The statistical analysis showed a significant increase for the IKDC (subjective, objective) and the Lysholm Score at final follow-up among each single technique, while we found no significant difference between the two reconstruction methods. On the basis of our investigation, we conclude that reconstruction of the ACL by a double-bundle ST graft with an extracortical anchorage can achieve excellent clinical results. But in contrast to our initial hypothesis, we could not quote any significant advantages by creating two independent bundles. Reconstruction of the anterior cruciate ligament in conventional single-bundle technique with a more horizontal femoral tunnel placement obtains comparable clinical results in the present high-demand collective. The objective of this study was to analyze and compare the results obtained after 2 types of treatment, surgical and conservative, for acute patellar dislocations.
                We divided 33 patients with acute patellar dislocations into 2 groups. One group with 16 patients underwent conservative treatment (immobilization and subsequent physiotherapy), and the other group with 17 patients underwent surgical treatment. A radiographic examination was performed in the evaluation of the patients to verify predisposing factors for patellofemoral instability, and the Kujala questionnaire was applied with the intention of analyzing the improvement of pain and quality of life. The chi(2) test, t test, and Fisher test were used in the statistical evaluation. A significance level of P < .05 was adopted.
                The groups were considered parametric in relation to age and sex. The conservative treatment group exhibited a higher number of recurrent dislocations (8 patients) than the surgical treatment group, which did not have any relapses. In addition, the surgical treatment group obtained a better mean score on the Kujala test (92) than the conservative treatment group (69).
                We conclude that surgical treatment afforded better results. There were no recurrences in the surgical treatment group, but there were 8 recurrences in the conservative treatment group. The mean Kujala score was 92 in the surgical treatment group and 69 in the conservative treatment group.
                Level II, lesser-quality therapeutic randomized controlled trial. We report on the results of a prospective randomised controlled trial to evaluate the use of an intra-articular drain following arthroscopically assisted ACL reconstruction using patellar tendon autograft. Forty-nine patients were recruited for the trial and randomised into receiving or not receiving a drain following surgery. An independent observer who was blinded for the use of the drain assessed the knees for swelling, range of movement (ROM) and pain at 2, 4 and 6 weeks postoperatively. Muscle strength was assessed at 12 weeks following surgery using the KIN COM III isometric dynamometer. We found that the knees that were drained following surgery initially had less swelling and a better ROM. However, at 4 weeks this difference had disappeared. At 3 and 6 months, there was no functional difference between the two groups. We recommend that no drain be used following ACL reconstruction as removal of the drain is uncomfortable and carries theoretical and avoidable risks.
There is insufficient evidence from randomised trials to determine whether surgery or conservative management was best for ACL injury in the 1980s, and no evidence to inform current practice. Good quality randomised trials are required to remedy this situation.