Aims

Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments.

Background

The PATH-2 trial found no evidence of a benefit of Platelet Rich Plasma (PRP) injection versus a placebo after Achilles tendon rupture (ATR) at six-months. ATR often leave longer-term functional deficiencies beyond six-months. This study aim is to determine if PRP affect tendon functional outcomes at two-years after rupture.

Background

Disability and slow return to sport and work after tendon rupture are major challenges. Platelet Rich Plasma (PRP) is an autologous supraphysiological concentration of platelets from whole blood that has demonstrated positive cellular and physiological effects on healing in laboratory conditions but evidence from adequately powered robust clinical trials is lacking. We aimed to determine the clinical efficacy of PRP for treatment of acute Achilles tendon rupture.

There is an increasing incidence of revision for periprosthetic joint infection. The addition of vancomycin to beta-lactam antimicrobial prophylaxis in joint arthroplasty may reduce surgical site infections, however, the efficacy and safety have not been established.

This was a multicenter, double-blind, superiority, placebo-controlled trial. We randomized 4239 adult patients undergoing joint arthroplasty surgery to receive 1.5g vancomycin or normal saline placebo, in addition to standard cefazolin antimicrobial prophylaxis. The primary outcome was surgical site infection at 90-days from index surgery. Perioperative carriage of Staphylococcus species was also assessed.

In the 4113 patients included in the modified intention-to-treat population, surgical site infections occurred in 72/2069 (3.5%) in the placebo group and 91/2044 (4. 5%) in the vancomycin group (risk ratio 1.28; 95% confidence interval 0.94 to 1.73; p value 0.11). No difference was observed between the two groups for primary hip arthroplasty procedures. A higher proportion of infections occurred in knee arthroplasty patients in the vancomycin group (63/1109 [4.7%]) compared with the placebo group (42/1124 [3.7%]; risk ratio 1.52; 95% confidence interval 1.04 to 2.23; p value 0.031). Hypersensitivity reactions occurred in 11 (0.5%) patients in the placebo group and 24 (1.2%) in the vancomycin group (risk ratio 2.20; 95% confidence interval 1.08, 4.49) and acute kidney injury in 74 (3.7%) patients in the placebo group and 42 (2.1%) in the vancomycin group (risk ratio 0.57; 95% confidence interval 0.39, 0.83). Perioperative Staphylococcus aureus carriage was detected in 1089/3748 (29.1%) of patients.

This is the first randomized controlled trial examining the addition of a glycopeptide antimicrobial to standard beta-lactam surgical antimicrobial prophylaxis in joint arthroplasty. The addition of vancomycin to standard cefazolin prophylaxis was not superior to placebo for the prevention of surgical site infections in hip and knee arthroplasty surgery.

Background and purpose

Modic changes (MC) are a risk factor for development of chronic low back pain (CLBP). There is no agreement about the cause of inflammation in MC, but autoimmunity has been suggested. The aim of the study was to investigate whether treatment with lactic acid bacteria for 100 days was associated with change of disability and pain, via a change in the gut microbiota inducing a change in the immune system, in patients with CLBP and type 1 MC during one year follow-up.

Aims: To assess the efþcacy of repeated low-energy extracorporeal shock wave application (ESWA) for chronic plantar fasciitis in runners. Methods: 45 running athletes with intractable plantar heel pain were enrolled in a randomized single-blind trial with a parallel-group design and blinded independent observer, to evaluate the efþcacy of three applications of 2100 impulses of ESWA (Group I) compared with sham treatment (Group II). Follow-up examinations were done at six months, and at one year after ESWA. The primary efþcacy endpoint was reduction of subjectsñ self-assessment of pain on þrst walking in the morning on a visual analog scale (range, 0 Ð 10 points) at six months after shock wave application. Results: After six months self-assessment of pain on þrst walking in the morning as primary efþcacy endpoint showed a signiþcant reduction from an average 6.9 to 2.1 points in Group I, and from an average 6.9 to 4.7 points in Group II on the visual analog scale. The mean difference between both groups was 2.6 points (p= 0.0004; 95% CI: 1.3 Ð 3.9; power = 0.9). After twelve months pain on þrst walking in the morning showed a further reduction in both groups, to an average 1.5 points in Group I, and to 4.4 points in Group II (p < 0.0001). Conclusion: The current study showed that three treatments with 2100 impulses of low-energy ESWA were a safe and effective non-surgical method for treating chronic plantar fasciitis compared with sham therapy.