Study design

Retrospective case series.

Objectives

Both the rate and complexity of spine surgeries in elderly patients has increased. This study reports the outcomes of multilevel spine fusion in elderly patients and provides evidence on the appropriateness of complex surgery in elderly patients.

Methods

We identified 101 patients older than70 years who had ≥5 levels of fusion. Demographic, medical, and surgical data, and change between preoperative and >500 days postoperative health survey scores were collected. Health surveys were visual analogue scale (VAS), EuroQoL 5 Dimensions (EQ-5D), Oswestry Disability Index (ODI), Scoliosis Research Society questionnaire (SRS-30), and Short Form health survey (SF-12) (physical composite score [PCS] and mental composite score [MCS]). Minimal clinically important differences (MCIDs) were defined for each survey.

Results

Complications included dural tears (19%), intensive care unit admission (48%), revision surgery within 2 to 5 years (24%), and death within 2 to 5 years (16%). The percentage of patients who reported an improvement in health-related quality of life (HRQOL) of at least an MCID was: VAS Back 69%; EQ-5D 41%; ODI 58%; SRS-30 45%; SF-12 PCS 44%; and SF-12 MCS 48%. Improvement after a primary surgery, as compared with a revision, was on average 13 points higher in ODI (P = .007). Patients who developed a surgical complication averaged an improvement 11 points lower on ODI (P = .042). Patients were more likely to find improvement in their health if they had a lower American Society of Anesthesiologists or Charlson Comorbidity Index score or a higher metabolic equivalent score.

Conclusions

In multilevel surgery in patients older than 70 years, complications are common, and on average 77% of patients attain some improvement, with 51% reaching an MCID. Physiological status is a stronger predictor of outcomes than chronological age.

Background

Open tibia fractures are a major source of disability in low- and middle-income countries (LMICs) due to the high incidence of complications, particularly infection and chronic osteomyelitis. One proposed adjunctive measure to reduce infection is prophylactic local antibiotic delivery, which can achieve much higher concentrations at the surgical site than can safely be achieved with systemic administration. Animal studies and retrospective clinical studies support the use of gentamicin for this purpose, but no high-quality clinical trials have been conducted to date in high- or low-income settings.

Methods

We describe a protocol for a pilot study conducted in Dar es Salaam, Tanzania, to assess the feasibility of a single-center masked randomized controlled trial to compare the efficacy of locally applied gentamicin to placebo for the prevention of fracture-related infection in open tibial shaft fractures.

Discussion

The results of this study will inform the design and feasibility of a definitive trial to address the use of local gentamicin in open tibial fractures. If proven effective, local gentamicin would be a low-cost strategy to reduce complications and disability from open tibial fractures that could impact care in both high- and low-income countries.

Trial registration

ClinicalTrials.gov, Registration # NCT03559400 ; Registered June 18, 2018.