Does Participation in a Randomized Clinical Trial Change Outcomes? An Evaluation of Patients Not Enrolled in the SPRINT Trial.

Objectives: To determine the extent to which knowledge from clinical trial protocols is transferred to nonparticipating patients.

Design: Retrospective review of prospectively collected data from a large clinical trial.

Setting: Six level-1 international trauma centers.

Character, Incidence, and Predictors of Knee Pain and Activity After Infrapatellar Intramedullary Nailing of an Isolated Tibia Fracture.

Objective: To study the activity and incidence of knee pain after sustaining an isolated tibia fracture treated with an infrapatellar intramedullary nail at 1 year.

Design: Retrospective review of prospective cohort.

Setting: Multicenter Academic and Community hospitals.

(Sample) size matters! An examination of sample size from the SPRINT trial study to prospectively evaluate reamed intramedullary nails in patients with tibial fractures.

Introduction: Inadequate sample size and power in randomized trials can result in misleading findings. This study demonstrates the effect of sample size in a large clinical trial by evaluating the results of the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial fractures (SPRINT) trial as it progressed.

Methods: The SPRINT trial evaluated reamed versus unreamed nailing of the tibia in 1226 patients, and in open and closed fracture subgroups (N = 400 and N = 826, respectively).

Development and validation of an instrument to predict functional recovery in tibial fracture patients: the Somatic Pre-Occupation and Coping (SPOC) questionnaire.

Objective: To explore the role of patients' beliefs in their likelihood of recovery from severe physical trauma.

Methods: We developed and validated an instrument designed to capture the impact of patients' beliefs on functional recovery from injury: the Somatic Pre-Occupation and Coping (SPOC) questionnaire. At 6-weeks postsurgical fixation, we administered the SPOC questionnaire to 359 consecutive patients with operatively managed tibial shaft fractures.

Outcomes assessment in the SPRINT multicenter tibial fracture trial: Adjudication committee size has trivial effect on trial results.

Objective: To evaluate how the size of an outcome adjudication committee, and the potential for dominance among its members, potentially impacts a trial's results.

Study Design And Setting: We conducted a retrospective analysis of data from the six-member adjudication committee in the Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) Trial. We modeled the adjudication process, predicted the results and costs if smaller committees had been used, and tested for the presence of a dominant adjudicator.

Use of both Short Musculoskeletal Function Assessment questionnaire and Short Form-36 among tibial-fracture patients was redundant.

Objective: To compare the Short Musculoskeletal Function Assessment Dysfunction Index (SMFA DI) and the Short Form-36 Physical Component Summary (SF-36 PCS) scores among patients undergoing operative management of tibial fractures.

Study Design And Setting: Between July 2000 and September 2005, we enrolled 1,319 skeletally mature patients with open or closed fractures of the tibial shaft that were managed with intramedullary nailing. Patients were asked to complete the SMFA Questionnaire and SF-36 at discharge and 3, 6, and 12 months post-surgical fixation.

Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

Background: There remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.

Functional outcome following one-part proximal humeral fractures: a prospective study.

A prospective study was undertaken to determine if patients recover pre-injury level of shoulder function 1 year after 1 part proximal humeral fractures. Of the 67 patients enrolled, 43 were female and 24 male with an average age of 64.8 years (range, 25-90 years).

Complications of intramedullary Hagie pin fixation for acute midshaft clavicle fractures.

The purpose of this report was to evaluate patient outcomes after treatment of acute midshaft clavicle fractures with an intramedullary Hagie pin, including clinical results and the incidence of postoperative complications. Between 1993 and 2003, 16 patients who underwent intramedullary Hagie pin fixation of a midshaft clavicle fracture were identified. The medical records of each patient were reviewed to ascertain the mechanism of injury, indication for surgical intervention, and treatment course.

Preoperative assessment of tibial nail length: accuracy using digital radiography.

This study was performed to determine if picture archiving communication systems can provide a more accurate method of determining implant length for intramedullary tibial nailing. Postoperative radiographs of 40 patients who underwent intramedullary nailing of their tibial shaft fractures using picture archiving communication systems were retrieved. In phase one and two of this investigation, tibial nail lengths were measured using "measuring distance" and "measure calibration" tools displayed on the respective digital systems.

An extraperitoneal isolated vascularized bone marrow transplant model in the rat.

An isolated vascularized bone marrow transplant (iVBMT) model was previously developed in the rat to specifically study the role of bone marrow and its environment in a composite tissue allotransplant. An extraperitoneal model was successfully created to avoid laparotomy and cross-clamping of the great vessels. The extraperitoneal iVBMT model consisted of a left donor femur that was harvested with its nutrient vessels, anastomosed to the right femoral vessels in a syngeneic host, and then placed subcutaneously in the abdominal wall.