Short Versus Standard Intramedullary Nail for Trochanteric Hip Fractures

Status Completed

Clinical Trial Summary

In England each year over 65,000 people fracture their hip. Most of these patients are elderly females with the fracture occurring after a simple trip or stumble. Approximately half of these fractures are classified from their relationship to the hip joint capsule as extracapsular. The majority of these fractures are treated surgically by internal fixation using, either a plate and screws (sliding hip screw) or nail and screws (intramedullary nail). Recent randomised studies from Peterborough involving 1000 patients have indicated that there are modest benefits for treating this type of fracture with an intramedullary nail in comparison to a sliding hip screw. This study aims to progress from these earlier studies to determine if a slightly thinner and shorter intramedullary nail (175mm in length), has any significant advantages or disadvantages to the standard length (220mm) intramedullary nail. Both implants to be used in this study are in routine use around the world and are being used within their licenced indication. The study is therefore using two different designs of implant within their recommended area of use, but in which there is uncertainty as to which is the best design.

Clinical Trial Description

The trial will be run as close to the ideal trial methodology for a randomised trial as specified by the CONSORT statement as possible. This will include secure randomisation, intention to treat analysis, full reporting of outcomes and clinical follow-up by a person who is blinded to the prosthesis used. The trial will follow the code of good clinical practice as specified by the hospital trusts Research and Development Committee. In Peterborough all hip fracture patients are admitted to the acute trauma ward and transferred to the care of the Chief Investigator (Mr Martyn Parker (MJP)). Those patients that are willing to participant in this randomised trial are consented prior to surgery. Treatment follows standard evidence based protocols with follow-up of all patients in a hip fracture clinic. A comprehensive database is maintained for all patients containing both audit and research data. Included in this is a standardised assessment of outcome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02680028
Study type	Interventional
Source	Peterborough and Stamford Hospitals NHS Foundation Trust
Contact
Status	Completed
Phase	N/A
Start date	November 2015
Completion date	June 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02422355` - A Focused Registry on the Femoral Neck System (FNS) in Patients With Femoral Neck Fractures
Completed	`NCT02197065` - Pilot Study of Atorvastatin for Orthopedic Surgery Patients	Phase 2
Recruiting	`NCT01934946` - Rehabilitation Care for Hip Fracture	N/A
Terminated	`NCT01667913` - Reliability of 6-Minutes Walking Test in Hip Fracture Patients	N/A
Completed	`NCT01714336` - Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?	Phase 4
Terminated	`NCT01535781` - Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?	N/A
Completed	`NCT01174589` - Training of Patients With Hip Fracture	Phase 2
Active, not recruiting	`NCT02362971` - External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture	N/A
Completed	`NCT01382875` - The Comparison of Comprehensive Multi-disciplinary Program and Conventional Care Program on Fragility Fracture Elderly	Phase 3
Completed	`NCT02591342` - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture	N/A
Completed	`NCT01738776` - Nutritional Risk Factors for Hip Fracture: a Case Control Study	N/A
Suspended	`NCT00521716` - Safety and Efficacy of the WaisFix100i for Intracapsular Femoral Fracture Fixation	N/A
Terminated	`NCT00128115` - Treatment of Sarcopenia in Post-Hip Fracture Patients (0677-032)	Phase 2
Active, not recruiting	`NCT00345488` - Fast Track Admittance of Hip Fracture Patients	Phase 4
Completed	`NCT02409082` - Alzheimers Disease and Neuromarkers in Patients With Acute Hip Fractures	N/A
Recruiting	`NCT04626934` - Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients	N/A
Completed	`NCT06001996` - Comparison of Intraoperative- Postoperative Effects of Pericapsular Nerve Block and Fascia Iliaca Block in Hip Fracture
Recruiting	`NCT02635763` - Peripheral Nerve Blocks in Elderly Patients With Hip Fracture	N/A
Completed	`NCT00848913` - Strength Training After Hip Fracture Surgery	N/A
Completed	`NCT02190903` - A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.