NCT02680028

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

February 4, 2016

Last Update Submit

March 9, 2021

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

  • Regain of mobility as assessed by a mobility score

    Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg Br. 1993;75:797-8. Validation Kristensen MT, Bandholm T, Foss NB, Ekdahl C, Kehlet H. High inter-tester reliability of the new mobility score in patients with hip fracture. J Rehabil Med 2008;40:589-91. Mobility will be assessed using a scale of 0 to 9. Nine represents full mobility indoors and outdoors without walking aids; Zero represents a bed-bound patient.

    1 year

Study Arms (2)

Standard length intramedullary nail

ACTIVE COMPARATOR

220mm intramedullary nail

Device: targon pft nail

Short length intramedullary nail

EXPERIMENTAL

175mm intramedullary nail

Device: targon pft nail

Interventions

targon pft nailDEVICE

220 mm vs 175mm nail

Short length intramedullary nailStandard length intramedullary nail

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients admitted to Peterborough City Hospital with a trochanteric hip fracture (type A1 type A2) that is to be treated by internal fixation with an intramedullary nail.

You may not qualify if:

  • Patients who decline to participate or in whom consent or assent is not available
  • Patients admitted when MJP is not available to supervise treatment
  • Patients with pathological fractures from Paget's disease of bone secondaries from tumour
  • Patients with a Subtrochanteric fracture and those of the reversed and transverse fracture type (A3 fractures)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peterbrough City Hospital

Peterborough, United Kingdom

Location

Related Publications (1)

  • Parker MJ, Cawley S. Short (175 mm) versus standard (220 mm) length intramedullary nail for trochanteric hip fractures: a randomized trial of 229 patients. Bone Joint J. 2020 Mar;102-B(3):394-399. doi: 10.1302/0301-620X.102B3.BJJ-2019-0776.R3.

    PMID: 32114812RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • martyn parker

    Peterborough hospital nhs trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Orthopaedic Surgeon

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 11, 2016

Study Start

November 1, 2015

Primary Completion

May 1, 2018

Study Completion

June 1, 2019

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)