Systematic Review and Analysis of the Quality of Randomized Controlled Trials Comparing Reamed and Unreamed Intramedullary Nailing of Tibial Fractures.

OBJECTIVES

To evaluate the quality of research and reporting of randomized controlled trials comparing the use of reamed and unreamed intramedullary nails for tibial fractures with validated scoring systems.

DATA SOURCE

PubMed using the search terms "tibia" AND "reamed OR unreamed" AND "intramedullary OR nail." Filters were applied for the years 1991-2019, full articles, human subjects, and English language.

STUDY SELECTION

Inclusion criteria were (1) prospective and randomized trials, (2) studies reported >80% follow-up, and (3) articles amenable to scoring with the chosen scoring systems. Exclusion criteria were (1) skeletally immature patients or (2) incomplete data sets.

DATA EXTRACTION

Articles were assessed with the Coleman Methodology Score, the Consolidated Standards of Reporting Trials systems, and Cowan's Categorical Rating by 2 independent observers.

DATA SYNTHESIS

Scores for individual articles were averaged for the 2 observers. The total and subcategory scores for all included articles were also averaged with SD from both observers. Categories from the 2 grading systems with deficient reporting were measured as a percentage based on grading from both observers. Data were analyzed using kappa statistic and correlation coefficient to assess agreement and reliability.

CONCLUSIONS

All included articles supported the use of reamed tibial intramedullary nails, but the overall quality of the literature fell in the middle of both the modified Coleman Score and Consolidated Standards of Reporting Trials grading scheme ranges despite being Oxford Level 1.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.