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Preclinical assessment of gastrooesophageal tolerance of the new antiosteoporotic drug strontium ranelate: an endoscopic study in monkeys.

This study was aimed at evaluating the digestive tolerance of the new antiosteoporotic drug, strontium ranelate, and to compare it to that of another strontium salt, strontium chloride (SrCl2). Strontium ranelate, SrCl2, or placebo were administered orally (capsules) to 3 groups of 2 male and 2 female cynomolgus monkeys (Macaca fascicularis) once a day for 7 days at a dose of 2 g/day, which is the recommended therapeutic dose in man. Endoscopic examination of the oesophagus, the stomach and the first part of the duodenum was performed on fasted animals approximately 3 hr after the first (Day 1) and last dosing (Day 7), and, on Day 8 and Day 14 in case of lesions on Day 7. Strontium ranelate did not induce any acute or subchronic toxic effect on the gastric mucosa, the oesophagus and the first part of the duodenum. On the contrary, acute and superficial damages were noted on all animals receiving SrCl2 such as haemorrhagic and erosive lesions (formation of an ulcer in one male and a marked congestive antritis in one female). These effects were reversible after cessation of treatment. The microscopic examination of biopsies sampled at the site of gastric lesions revealed moderate granulocyte infiltration, indicating a local irritating origin of the lesions. Strontium ranelate by oral route is safe for the gastric mucosa while SrCl2 induced superficial and reversible lesions.

Administration, Oral↗

A comparison of oral ketorolac and hydrocodone-acetaminophen for analgesia after ambulatory surgery: arthroscopy versus laparoscopic tubal ligation.

This multicenter study compared the analgesic efficacy and side effects of ketorolac and hydrocodone-acetaminophen when administered orally after ambulatory arthroscopic or laparoscopic tubal ligation procedures. After awakening from general anesthesia, 252 patients experiencing moderate or severe postoperative pain were randomly assigned to receive one of three analgesic treatments according to a placebo-controlled, double-blind protocol. Group 1 (n = 83) received oral ketorolac 10 mg every 6 h for up to 3 days, Group 2 (n = 82) received hydrocodone 7.5 mg plus acetaminophen 750 mg every 6 h for up to 3 days, and Group 3 (n = 87) received placebo capsules followed by ketorolac 10 mg every 6 h for up to 3 days. Severity of pain was recorded using a 4-point categorical score and visual analog scale (VAS) at 0.5 h and subsequently at hourly intervals for 6 h, as well as daily for up to 3 days. Pain relief was recorded using a 5-point categorical scale at the same time points. In the patients undergoing arthroscopic surgery, both ketorolac and hydromorphone-acetaminophen provided superior pain relief compared with the placebo. Although the categorical summed pain intensity difference (SPID), VAS SPID, and total pain relief scores were higher in the ketorolac group compared with the hydrocodone-acetaminophen group, the differences were not statistically significant. In the patients undergoing laparoscopic tubal ligation surgery, the three treatment groups displayed similar responses to the study medications. However, the ketorolac group scored higher in terms of overall tolerability than the hydrocodone-acetaminophen group. In conclusion, there was no difference in the efficacy between oral ketorolac and hydrocodone-acetaminophen combination in controlling pain after outpatient arthroscopic surgery procedures. Neither oral analgesic proved to be very effective after laparoscopic tubal ligation.

Acetaminophen↗

Arthroscopic release for chronic, refractory adhesive capsulitis of the shoulder.

Idiopathic adhesive capsulitis usually responds to gentle physical therapy or, if that fails, to closed manipulation with the patient under anesthesia. In some patients, however, loss of motion may be refractory to either of these treatments and an operative release may be indicated. We are reporting on the technique and results of arthroscopic capsular release as a new alternative for the management of such patients. During a three-year period, we managed twenty-three patients who had idiopathic adhesive capsulitis that had failed to respond to physical therapy or closed manipulation. These patients had an arthroscopic anterior capsular release and received forty-eight hours of intensive physical therapy as inpatients. During the physical therapy, the patients received an interscalene regional analgesic with use of repeated nerve blocks or with a continuous infusion through an interscalene catheter. This was followed by a supervised outpatient physical-therapy program. Six patients also had an arthroscopic acromioplasty for the treatment of impingement. There were no complications related to any of the procedures. At a mean of thirty-nine months (range, twenty-four to sixty-four months) after the arthroscopic procedure, the improvement in the score of Constant and Murley averaged 48 points (range, 13 to 77 points). The mean improvement in motion was 49 degrees (range, 0 to 105 degrees) for flexion; 42 degrees (range, 10 to 80 degrees) and 53 degrees (range, 0 to 100 degrees) for external rotation in adduction and abduction, respectively; and eight spinous-process levels (range, three to fourteen levels) and 33 degrees (range, 30 to 60 degrees) for internal rotation in adduction and abduction, respectively. These gains in motion were all significant (p < 0.01) compared with the preoperative values and were within a mean of 7 degrees of the values for the contralateral, normal shoulder. We concluded that, in patients who have loss of motion that is refractory to closed manipulation, arthroscopic capsular release improves motion reliably with little operative morbidity.

Adult↗

Effect of simulated shoulder thermal capsulorrhaphy using radiofrequency energy on glenohumeral fluid temperature.

PURPOSE: To determine joint fluid temperatures at different time intervals during treatment with radiofrequency energy (RFE) applied in intermittent and continuous treatment manners under flow or no-flow conditions using a simulated shoulder joint model. TYPE OF STUDY: In vitro measurement of simulated joint fluid temperature during RFE treatment. METHODS: A custom-built jig with a chamber (volume size, 25 mL) was used to mimic the adult human shoulder. Three RFE systems: Vulcan EAS plus TAC-S probe (Smith & Nephew Endoscopy, Andover, MA); VAPR II plus End-Effect Electrode (Mitek, Westwood, MA); and ArthroCare 2000 plus TurboVac 90 degrees probe (ArthroCare, Sunnyvale, CA) were tested in the chamber with saline solution initially set at 23 degrees C. Each RFE probe was applied in a paintbrush pattern on the capsular tissue in the chamber and a fluoroptic thermometry probe was placed 1 cm above the RFE treatment probe to record the fluid temperature. Both intermittent and the continuous treatment manners were tested under flow and no-flow conditions. For each probe/manner/flow combination, 6 bovine capsular tissue specimens were tested (n = 6). All data were recorded using a HyperTerminal software program (Hilgraeve Inc, Monroe, MI) into a personal computer. RESULTS: When using intermittent and continuous treatment manners with flow, all recorded chamber fluid temperatures for all tested RFE probes at each time interval were below 40 degrees C. Under no-flow conditions, with intermittent treatment, the ArthroCare probe caused joint fluid temperatures to exceed 50 degrees C after 70 seconds of RFE treatment. With the continuous treatment, the ArthroCare caused chamber fluid temperatures to exceed 65 degrees C after 2 minutes of treatment. The highest mean recorded chamber fluid temperature was caused by ArthroCare probe, which reached 80 degrees C at 3 minutes. For all probes, continuous treatment caused significantly higher chamber fluid temperatures than intermittent treatment. CONCLUSIONS: The results of this study indicate that using flow during thermal capsulorrhaphy could lower joint fluid temperature to prevent heated joint fluid from killing chondrocytes of articular cartilage, and the intermittent treatment manner caused lower fluid temperature compared with continuous treatment within the RFE-treated shoulder joint. CLINICAL RELEVANCE: Articular cartilage of the humeral head may suffer potential thermal injury from heating of joint fluid during RFE thermal capsulorrhaphy.

Animals↗

Arthroscopic release of postoperative capsular contracture of the shoulder.

A loss of motion after an operation on the shoulder often cannot be treated successfully with physical therapy or closed manipulation. Although open release techniques generally improve motion, they involve extensive dissection. We developed a technique of arthroscopic capsular release and applied it in eighteen patients who had postoperative stiffness of the shoulder. The patients were selected for the arthroscopic release technique if a conservative program of physical therapy and an attempted closed manipulation had failed to restore motion and if they had no known extra-articular contractures. Five of the thirteen patients who had had a global loss of shoulder motion had motion restored with the anterior capsular release, and six needed an additional release of the posterior aspect of the capsule--that is, a combined (anterior and posterior) capsular release. The arthroscopic procedure could not be completed in the remaining two patients because of an extra-articular scar involving the subscapularis, but those patients were managed successfully with an open release. As five patients had lost only internal rotation and flexion, they had only a posterior capsular release. For the eleven patients who had had either an anterior or a combined (anterior and posterior) capsular release, the mean improvement in the score of Constant and Murley was 43 points (range, 31 to 62 points) and all improvements in motion were significant (p < 0.01). Flexion improved a mean of 51 degrees (range, 10 to 65 degrees); external rotation in adduction and abduction, 31 degrees (range, 10 to 50 degrees) and 40 degrees (range, 5 to 80 degrees), respectively; and internal rotation in adduction and abduction, six spinous-process levels (range, three to eleven levels) and 41 degrees (range, 20 to 70 degrees), respectively. For the five patients who had an isolated posterior capsular release, the score of Constant and Murley improved a mean of 20 points (range, 5 to 35 points) and the improvements in motion also were significant (p < 0.05 and 0.005). Internal rotation in adduction and abduction improved a mean of four spinous-process levels (range, one to ten levels) and 42 degrees (range, 30 to 60 degrees), respectively. Eight patients had an arthroscopic acromioplasty for concomitant impingement disease. One patient who had had a combined (anterior and posterior) release and one who had had a posterior capsular release continued to have pain because of injury of the articular cartilage from a previous operation. We concluded that arthroscopic capsular release is a reliable method for restoring motion with minimum morbidity in carefully selected patients who have postoperative stiffness of the shoulder. When necessary, it can be converted to an open release.

Adult↗

[Treatment strategy in first traumatic anterior dislocation of the shoulder. Plea for a multi-stage concept of preventive initial management].

The purpose of this paper is to outline the treatment protocol for the first time traumatic anterior shoulder dislocator, with options including conservative, arthroscopic and open surgical treatment. Regarding the subclassification of the first time traumatic anterior dislocater, it is imparitive to differentiate between the unidirectional dislocator with and without hyperlaxity. This subclassification takes into account the structural quality of the stabilizing ligamentous structures of the glenohumeral capsule. The patient with hyperelastic ligaments exhibit elastic deformation of the glenohumeral ligaments at the time of dislocation and thus, sustain less interstitial structural damage to the ligament. Therefore, these patients benefit from non-operative treatment. There are extrinsic and intrinsic factors which determine the outcome of the primary traumatic anterior shoulder dislocation. Extrinsic factors are those that are not related to changes in the shoulder morphology. The most important extrinsic factor is the age of the patient at the time of injury. The younger the patient at the time of injury the greater the risk of recurrence. As a rule, those patients 25 years of age or less, at the time of initial injury are less likely to spontaneously stabilize without surgical intervention, than they are to develop recurrence. Secondly, the type and level of sport participation is related to recurrence. Although the severity of the trauma can not be quantified, it certainly has an influence on recurrence. Immobilization remains controversial. A rehabilitation program is more likely to be successful in atraumatic instability. Patient compliance is important regardless of the type of treatment selected. Intrinsic factors include injury to the various anatomic structures about the shoulder, occurring at the time of primary anterior shoulder dislocation. A deep Hill Sachs lesion is more likely to result in recurrence secondary to both the impaction of the bone, as well as, the reduction of the area of articular surface. A displaced bony Bankart is a highly unstable situation secondary to the loss of the butress to retain the humeral head. In contrast to a Hill Sachs lesion or a bony Bankart, a concomittent fracture of the greater tuberosity is unlikely to result in recurrent dislocation. Isolated laberal detachment is not related to recurrence, but a complete disruption of the laberal ligament complex is highly correlated with recurrence. A rare subluxation erecta, as a special form of traumatic inferior instability, has a high recurrence rate. With increasing age there is a higher risk of concomittent rotator cuff tear. In most situations surgical repair of the rotator cuff tear results in resolution of the instability. The essential issue in determining the treatment protocol is to define concomittent hyperlaxity in the injured shoulder. Concomittent hyperlaxity precludes initial surgical treatment. The orthopedic surgeon treating the patient at the time of injury needs to design a concise treatment protocol for the patient based on the assessment of the extrinsic and intrinsic factors. An unreducable shoulder dislocation or associated vascular injury requires emergent intervention. Absolute indications for surgical treatment include: persistent dislocation, bony Bankart, a grossly displaced greater tuberosity fracture, and rupture of the subscapularis tendon. Surgical stabilization of primary anterior traumatic dislocation is indicated if the following strict criteria are met: adequate trauma, no self reduction, unidirectional instability without hyperlaxity, Hill Sachs lesion, age below 26 years, high level of sport activity and the special situation of luxatio erecta. Post primary stabilization is indicated for persistent subluxation, subjective instability or demonstrated pathologic instability tests. Rotator cuff tears due to traumatic dislocation in the elderly population require surgical repair.

Arthroscopy↗