NASHA hyaluronic acid vs. methylprednisolone for knee osteoarthritis: a prospective, multi-centre, randomized, non-inferiority trial.

OBJECTIVE: To compare NASHA hyaluronic acid gel as single-injection intra-articular (IA) treatment for knee osteoarthritis (OA) against methylprednisolone acetate (MPA). DESIGN: This was a prospective, multi-centre, randomized, active-controlled, double-blind, non-inferiority clinical trial. A unique, open-label extension phase (OLE) was undertaken to answer further important clinical questions. Subjects with painful unilateral knee OA were treated and followed for 26 weeks (blinded phase). All patients attending the clinic at 26 weeks were offered NASHA treatment, with a subsequent 26-week follow-up period (extension phase). The primary objective was to show non-inferiority of NASHA vs MPA in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain responder rate (percentage of patients with ≥40% improvement from baseline in WOMAC pain score and an absolute improvement of ≥5 points) at 12 weeks. RESULTS: In total, 442 participants were enrolled. The primary objective was met, with NASHA producing a non-inferior response rate vs MPA at 12 weeks (NASHA: 44.6%; MPA: 46.2%; difference [95% CI]: 1.6% [-11.2%; +7.9%]). Effect size for WOMAC pain, physical function and stiffness scores favoured NASHA over MPA from 12 to 26 weeks. In response to NASHA treatment at 26 weeks, sustained improvements were seen in WOMAC outcomes irrespective of initial treatment. No serious device-related adverse events (AEs) were reported. CONCLUSIONS: This study shows that single-injection NASHA was well tolerated and non-inferior to MPA at 12 weeks. The benefit of NASHA was maintained to 26 weeks while that of MPA declined. An injection of NASHA at 26 weeks conferred long-term improvements without increased sensitivity or risk of complications. STUDY IDENTIFIER: NCT01209364 (www.clinicaltrials.gov).

Diet and muscle glycogen concentration in relation to physical performance in Swedish elite ice hockey players.

The effects of carbohydrate (CHO) loading on physical characteristics including muscle fiber distribution, muscle glycogen concentration, and physical performance were studied in two top Swedish ice hockey teams. Players were randomly allocated to two groups: those consuming a CHO-enriched diet (CHO group) and those consuming a mixed diet (controls). Biopsies from the vastus lateralis muscle were taken three times: after Game 1, before Game 2, and after Game 2. Muscle fiber distribution averaged 50 +/- 2% slow twitch fibers (mean +/- 1 SEM). Muscle glycogen concentrations (measured in mmol glucose units . kg-1 wet muscle) were as follows: after Game 1, 43 +/- 4 (all players); before Game 2, 99 +/- 7 (CHO group) and 81 +/- 7 (controls); and after Game 2, 46 +/- 6 (CHO group) and 44 +/- 5 (controls). Distance skated, number of shifts skated, amount of time skated within shifts, and skating speed improved with CHO loading. It was concluded that individual differences in performance could be related to muscle glycogen metabolism.

Glycosaminoglycan polysulfate injections in lateral humeral epicondylalgia: a placebo-controlled double-blind trial.

The purpose of this study was to investigate the therapeutic benefit of local Glycosaminoglycan polysulfate (GAGPS) injections in the treatment of chronic epicondylalgia. The study was conducted as a prospective, placebo-controlled double-blind trial. Sixty patients with a typical history of pain for at least 3 months who attended two private orthopaedic clinics in Stockholm received 50 mg GAGPS or placebo injections, one injection a week, for five weeks. The main outcome measures were the patients' evaluation of pain in connection with daily activities with a visual analogue scale and the number of treatment failures. The follow-up period was six months. The difference in reduction of painscore (VAS) ranging between 11.1 percentage units at the half-year follow-up and 20.9 percentage units 2 weeks after the treatment period is clinically good. The number of treatment failures in the GAGPS treatment groups at the 6 week follow-up was only 4 (13%) compared with 12 (40%) of the placebo treated patients. At the half-year follow-up 5 of those who received GAGPS had experienced a recurrency. The recurrency rate is thus smaller than most of those reported in controlled studies with corticosteroids. In the GAGPS treated group 13 patients reported on local pain after some injections, 2 cases combined with local haematomas, compared with 5 cases of local pain in the placebo group. The results confirm previous good results of GAGPS injection therapy in subchronic and chronic peritendinitis.

Tenotomy of the adductor longus tendon in the treatment of chronic groin pain in athletes.

Eighteen tenotomies of the adductor longus tendon were performed in 16 consecutive male athletes (aged 20 to 42) as treatment for chronic groin pain. The criteria for surgery was a history of long-standing (range, 2.5 to 48 months) and distinct pain at the origin of the adductor longus muscle, refractory to conservative treatment. At followup 35 months (range, 4 to 84) after surgery, all patients were improved or free of symptoms. All but 1 of the athletes returned to the same sport within a mean of 6.6 weeks, and 12 of 16 returned to competitive sports within a mean of 14 weeks after surgery. A majority of the patients (10 of 16) returned to full athletic activity, whereas 5 of 16 performed at a reduced level. One patient discontinued his sports activity due to other causes. In conclusion, when conservative treatment fails, tenotomy of the adductor longus tendon gives good long-term functional results in the treatment of chronic groin pain that is localized at the origin of the adductor longus muscle. A decreased muscle strength was observed in this study and did not seem to influence participation in sports.

Topical indomethacin in overuse injuries in athletes. A randomized double-blind study comparing Elmetacin with oral indomethacin and placebo.

In this double-blind trial in 70 athletes with superficial overuse injuries, the effect of topically and systemically administered indomethacin was compared with a placebo control. The treatment period was 2 weeks and blindness was secured by the double-dummy technique. The basic data of the patients showed no significant differences on entry to the study. The majority of cases were acute or subacute, the mean duration of symptoms being 7.4 weeks. The results showed a marked therapeutic effect after 3-7 days of treatment and statistically significant differences between the topical formulation and the placebo were reached in the parameters patients assessment of improvement and pain in connection with daily activity within the first week of treatment. However, during the second week the statistical significances were lost. Only in the topically treated patients local adverse reactions were observed. In the oral indomethacin group all reactions were systemic, GI- and CNS-complaints being predominant. The results on efficacy as well as adverse reactions favour the use of topical indomethacin in superficial overuse injuries in athletes.

The coracoid transfer for recurrent dislocation of the shoulder. Technical aspects of the Bristow-Latarjet procedure.

One hundred and twelve shoulders with recurrent anterior dislocation were treated with the Bristow-Latarjet procedure and had a two to five-year follow-up after surgery. The incidence of redislocation was 6 per cent, and an additional 7 per cent of the patients reported occasional subluxation. In 106 shoulders, a radiographic study was carried out in order to determine the importance of factors such as healing and position of the transferred coracoid process with regard to the postoperative clinical results. No redislocation or subluxation occurred in the forty patients in whom the transplant showed osseous or fibrous union at the scapula and was located inferior to the equator of the glenoid and less than one centimeter medial to its rim. In shoulders in which either the transplant had migrated more than 1.5 centimeters from that position or was placed one centimeter or more medial to the glenoid rim, the incidence of redislocation or subluxation was significantly increased.

Bristow-Latarjet procedure for recurrent anterior dislocation of the shoulder. A 2-5 year follow-up study on the results of 112 cases.

A follow-up study of 111 out of 112 patients operated on for shoulder joint dislocation according to the Bristow-Latarjet procedure during the years 1975 through 1979 in four Swedish hospitals is presented. The average follow-up time was 30 months (range 24-60 months). There were seven cases of significant recurrences (6 per cent). During follow-up, further surgery had been performed on four of these. Another eight patients (7 per cent) had experienced occasional insignificant subluxations. In one case neurolysis of the musculocutaneous nerve was undertaken because of postoperative paresis of elbow flexors. The average limitation of outward rotation as compared with the nonoperated side was 19 degrees in adduction and 21 degrees in abduction. There was a measurable difference in strength between the operated and nonoperated shoulders. The results were considered excellent or good by 101 of the patients (90 per cent), fair by eight and bad by three. Of 12 cases with failed surgery before the Bristow-Latarjet procedure 10 regarded the result as good or excellent.