Ilkka Sinisaari

Metallic or absorbable implants for ankle fractures: a comparative study of infections in 3,111 cases.

Absorbable fracture fixation has been in clinical use since 1984. Our study compares the infection rates and some infection parameters between metallic (2073 patients) and absorbable fracture fixation devices (1012 patients) in displaced ankle fractures. The infection rate associated with metallic fixation was 4.1%, compared with 3.2% absorbable fixation (p 0.3). The patients who had a wound infection were older when metallic fixation was used (p 0.01). They also had a bi- or trimalleolar fracture more often than did patients treated with absorbable fracture fixation, but this difference did not have a significant effect on the wound infection rate (p 0.2). The infections were mostly caused by microorganisms of the Staphylococcus species. Deep infections were equally common with both fixation methods (0.4%), but there was some variation in the bacterial spectrum.

Wound infections associated with absorbable or metallic devices used in the fixation of fractures, arthrodeses and osteotomies.

SummaryTotally absorbable internal fixation devices have been used in a total of 2114 operations for the treatment of fractures, arthrodeses and osteotomies at our department between November 1984 and December 1992. The infection rate was 3,5%, for pure polyglycolide (PGA) implants 4% and for pure polylactide (PLLA) implants 0,7%. When the fixation with absorbable implants was compared to that of metallic implants in another series the infection rates were 4% and 9%, respectively. This difference was due to technical reasons. Sinus formation due to a foreign body reaction was observed in 2,5% of 2114 cases and was subsequently infected in 20%.RésuméLes implants entièrement biodégradables pour la fixation interne ont été utilisés dans 2114 opérations pour le traitement des fractures, des arthrodèses et des ostéotomies dans notre clinique de novembre 1984 à décembre 1992. Le nombre d’infections en général a été 3,5%; pour les implants polyglycolide (PGA) 4%, et pour les implants polylactide (PLLA) 0,7%. La comparaison des implants biodégradables aux implants métalliques dans une autre série, le nombre d’infection était respectivement de 4 et 9%. Cette differénce résulte de causes techniques. La fistulisation comme réaction inflammatoire locale à corps étranger a été observée dans 2,5% de 2114 cas, et 20% de ces cas étaient secondairement infectés.

Effect of totally absorbable implant volume on wound infection rate: Study of 2500 operated fractures, osteotomies, and ligament injuries

Between November 1984 and January 1994 in our department, a total of 2500 patients were treated with totally absorbable internal fixation devices. We studied these patients and analyzed results with regard to the volume of the absorbable implants and the development of wound infection. Of the 2500 patients 2044 were trauma patients and 456 were operated on for orthopedic disease. In 1466 patients treated with implants made of self-reinforced polyglycolic acid (SR-PGA) only, the patients who developed wound infection had a higher implant volume (P=0.07) than those who did not; this difference was close to statistical significance. In the 446 patients who received only implants made of self-reinforced poly-l-lactic acid (SR-PLLA), the 5 who developed wound infection had a mean implant volume more than three times that of the non-infected patients (P=0.01). We found that in the patients treated with the earlier SR-PGA implants, which contained a green staining material, there was no correlation between implant volume and incidence of wound infections. On the other hand, both the non-stained SR-PGA implants, which have been in clinical use since 1989, and the SR-PLLA implants, seem to be more predictable in terms of wound infections. We believe that this difference, is largely due to the lower level of tissue reactions with these newer implants.

Subacromial decompression versus diagnostic arthroscopy for shoulder impingement: randomised, placebo surgery controlled clinical trial

Abstract Objective To assess the efficacy of arthroscopic subacromial decompression (ASD) by comparing it with diagnostic arthroscopy, a placebo surgical intervention, and with a non-operative alternative, exercise therapy, in a more pragmatic setting. Design Multicentre, three group, randomised, double blind, sham controlled trial. Setting Orthopaedic departments at three public hospitals in Finland. Participants 210 patients with symptoms consistent with shoulder impingement syndrome, enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015. Interventions ASD, diagnostic arthroscopy (placebo control), and exercise therapy. Main outcome measures Shoulder pain at rest and on arm activity (visual analogue scale (VAS) from 0 to 100, with 0 denoting no pain), at 24 months. The threshold for minimal clinically important difference was set at 15. Results In the primary intention to treat analysis (ASD versus diagnostic arthroscopy), no clinically relevant between group differences were seen in the two primary outcomes at 24 months (mean change for ASD 36.0 at rest and 55.4 on activity; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity). The observed mean difference between groups (ASD minus diagnostic arthroscopy) in pain VAS were −4.6 (95% confidence interval −11.3 to 2.1) points (P=0.18) at rest and −9.0 (−18.1 to 0.2) points (P=0.054) on arm activity. No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events. In the secondary comparison (ASD versus exercise therapy), statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest (−7.5, −14.0 to −1.0, points; P=0.023) and VAS on arm activity (−12.0, −20.9 to −3.2, points; P=0.008), but the mean differences between groups did not exceed the pre-specified minimal clinically important difference. Of note, this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group, without comparable exclusions from the exercise therapy group. Conclusions In this controlled trial involving patients with a shoulder impingement syndrome, arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months. Trial registration Clinicaltrials.gov NCT00428870.