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.
Methods: We compared rates and timing of reoperation in a subset of patients enrolled in the Study to Prospectively evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) to concurrent patients who were eligible but not enrolled. This was a retrospective review of prospectively collected trial data. The records of 6 of the original SPRINT centers were searched for non-SPRINT patients who underwent intramedullary nailing of a closed tibial fracture. The rate and timing of reoperation were compared. A P < 0.05 was considered significant.
Results: One hundred fourteen non-SPRINT patients were compared with 328 patients enrolled in SPRINT from those same sites. There were 7 reoperations (6.1%) in non-SPRINT patients versus 18 (5.2%) in SPRINT patients [odds ratio (OR) 1.19, 95% confidence interval (CI) 0.41 to 3.13; P = 0.811]. There was no difference in the time to reoperation between the SPRINT and non-SPRINT patients (6.2 vs. 6.8 months, 95% CI of the difference -3.8 to 2.6; P = 0.685) or in the proportion of patients who underwent reoperation before 6 months (29% vs. 43%; OR 1.75; 95% CI 0.18 to 15.41; P = 0.647).
Conclusions: Patients not enrolled in SPRINT had similarly low rates of reoperation for nonunion, and the average time to reoperation for both groups was longer than 6 months. A 6-month waiting period may have allowed slow-to-heal fractures adequate time to heal, thereby reducing the rate of diagnosis of nonunion. As such, this waiting period could contribute to lower-than-expected reoperation rates for nonunion. It is possible that clinical trials may beneficially influence the care of nonenrolled patients.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1097/bot.0000000000000533 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Inheritance of Imaging Parameters of Arrhythmic Risk in Mitral Valve Prolapse: A Pedigree Study.
Circ Cardiovasc Imaging
January 2025
Division of Cardiology, Department of Medicine, University of California, San Francisco (L.C., S.D., D.B., J.J.T., Q.F., L.T., A.H.R., R.J., S.H., H.H.H., Z.H.T., N.B.S., F.N.D.).
Background: A subset of patients with mitral valve prolapse (MVP), a highly heritable condition, experience sudden cardiac arrest (SCA) or sudden cardiac death (SCD). However, the inheritance of phenotypic imaging features of arrhythmic MVP remains unknown.
Methods: We recruited 23 MVP probands, including 9 with SCA/SCD and 14 with frequent/complex ventricular ectopy.
Safety and clinical efficacy of neoadjuvant chemoradiation therapy with immunotherapy for organ preservation in ultra-low rectal cancer: preliminary results of the CHOICE-I trial: a prospective cohort study.
Int J Surg
January 2025
Department of Colorectal Surgery.
Objective: To explore the safety and efficacy of neoadjuvant chemoradiotherapy (nCRT) combined with a PD-1 antibody in improving complete clinical response (cCR) and organ preservation in patients with ultra-low rectal cancer.
Methods: This was a prospective phase II, single-arm, open-label trial. Patients with confirmed pMMR status T1-3aN0-1M0 retcal adenocarcinoma were included.
Effect of psilocybin versus escitalopram on depression symptom severity in patients with moderate-to-severe major depressive disorder: observational 6-month follow-up of a phase 2, double-blind, randomised, controlled trial.
EClinicalMedicine
October 2024
Centre for Psychedelic Research, Division of Psychiatry, Department Brain Sciences, Imperial College London, United Kingdom.
Background: Psilocybin therapy (PT) produces rapid and persistent antidepressant effects in major depressive disorder (MDD). However, the long-term effects of PT have never been compared with gold-standard treatments for MDD such as pharmacotherapy or psychotherapy alone or in combination.
Methods: This is a 6-month follow-up study of a phase 2, double-blind, randomised, controlled trial involving patients with moderate-to-severe MDD.
Predictors of response to bDMARDs and tsDMARDs in psoriatic arthritis: a pilot study on the role of musculoskeletal ultrasound.
Front Med (Lausanne)
December 2024
Rheumatology Unit, Department of Medicine-DIMED, University - Padova University Hospital, Padua, Italy.
Objectives: This pilot study aimed to identify early predictors of drug retention in patients with clinically active peripheral psoriatic arthritis who initiated or switched to therapy with biologic and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs).
Methods: Clinical and ultrasound assessments were conducted at baseline (t0) and subsequently at 1 (t1), 3 (t3), and 6 (t6) months. Ultrasound evaluations targeted joints/entheses according to PsASon-Score13 and the most clinically involved joint/enthesis/tendon or the two most clinically involved joints/entheses/tendons (MIJET and 2MIJET).
L-arginine in patients with spinocerebellar ataxia type 6: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
EClinicalMedicine
December 2024
Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.
Background: Therapeutic advancements for the polyglutamine diseases, particularly spinocerebellar degeneration, are eagerly awaited. We evaluated the safety, tolerability, and therapeutic effects of L-arginine, which inhibits the conformational change and aggregation of polyglutamine proteins, in patients with spinocerebellar ataxia type 6 (SCA6).
Methods: A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (clinical trial ID: AJA030-002, registration number: jRCT2031200135) was performed on 40 genetically confirmed SCA6 patients enrolled between September 1, 2020, and September 30, 2021.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!