Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

OBJECTIVE: Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. DESIGN: Prospective, nonrandomized Food and Drug Administration approved pilot study. SETTING: Three centers in the United States. SUBJECTS: Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. INTERVENTIONS: Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). OUTCOME MEASURES: Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). RESULTS: Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. EFFICACY: Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. CONCLUSION: Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.

Tibial osteotomy for the treatment of varus gonarthrosis. Survival and failure analysis to twenty-two years.

BACKGROUND: The purpose of this retrospective study was to assess the long-term results after the treatment of medial compartment gonarthrosis with a proximal tibial osteotomy to determine whether various clinical and radiographic factors relate to the outcome. METHODS: From 1972 to 1990, seventy-six valgus-producing high tibial osteotomies were performed in sixty-six patients with medial compartment gonarthrosis. Stabilization was achieved with use of a plate on the lateral side of the proximal part of the tibia and a figure-of-eight wire on the medial side. The mean age of the patients at the time of surgery was sixty-nine years, and the mean duration of follow-up was 10.8 years. The factors that were analyzed included postoperative valgus alignment; the age, gender, and weight of the patient; preoperative Ahlbäck radiographic grade; adverse events; Workers' Compensation status; and public liability. Survivorship outcome end points were conversion to arthroplasty, a Hospital for Special Surgery knee score of <70 points, and patient dissatisfaction with the procedure. RESULTS: Ten-year survival, according to the life-table method, was 74%, 70%, and 65% with conversion to arthroplasty, a Hospital for Special Surgery knee score of <70 points, and patient dissatisfaction, respectively, as the end points. Radiographic valgus alignment that ranged between 8 degrees and 16 degrees at one year after the osteotomy had the most significant positive effect on survivorship for all end points (p < 0.01) compared with the other parameters. Complications occurred in sixteen (21%) of the seventy-six procedures, and they had a significant effect on survival, with all three end points (p < 0.05). CONCLUSIONS: We found that survival at ten years was 90% (95% confidence interval, 80% to 99%) when the radiographic valgus angle at one year was between 8 degrees and 16 degrees with arthroplasty as the end point. We believe that there is a role for tibial osteotomy, as an alternative to total knee arthroplasty, in patients who are less than sixty years old. LEVEL OF EVIDENCE: Therapeutic study, Level III-2 (retrospective cohort study). See Instructions to Authors for a complete description of levels of evidence.

Long-term follow-up of the GSB II total knee used in primary total knee arthroplasty.

The GSB II (Sulzer Medica, Winterthur, Switzerland) knee prosthesis ranks between the minimally constrained condylar prostheses and the fully constrained hinges. The senior author (T.R.S.) used this prosthesis in 47 patients (54 knees) with a maximum follow-up of 18 years (mean, 7.8 years). The mean patient age was 75 years (range, 61-94 years). The 10- and 18-year cumulative life-table survival rates were 95.7% and 88.1% for prosthesis removal or infection, 87.4% and 76.8% for patient dissatisfaction, and 81.5% and 71.3% for Hospital for Special Surgery score <70 or infection (95% confidence interval). The cumulative rate of infection after 10 and 18 years was 4.3% and 11.6% based on the life-table survival analysis. The only indication for this type of prosthesis in a primary arthroplasty is a knee with severe deformity, bone loss, or ligament deficiency.