Stabilization of Fresh Unilateral Unstable Pertrochanteric Hip Fracture

NCT02788994 | Unknown

• 1 other identifier: OR15/280
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preliminary study to establish the issues and potential of the investigators proposed project, which involves recruitment of patients with and without dementia, who have been admitted to hospital following hip fractures. The study will be evaluating the result of treatment of unstable pertrochanteric hip fractures focusing on how soon mobility is restored leading to their independence. These patients would require surgical fixation (not replacement) of their hip fractures. The study will evaluate two methods of fixation of hip fractures treated with either a pin (nail) which is inserted within the cavity of the thigh bone or a hip screw with a plate which is applied on the outer aspect of the thigh bone. The data collected from this study will provide information on whether one method of fixation is better than the other.

Conditions

Unilateral Unstable Hip

Outcome Measures

Primary Outcomes (1)

• All patients attending week 4 follow-up visit must be able to perform the TUG test at least once.

  The TUG test involves standing up from a seated position, walking three metres, turning around, and then walking three metres back to chair and returning to the seated position. The TUG times will be noted down in seconds/ minutes.

  4 weeks

Secondary Outcomes (1)

• The length of hospital stay for each patient

  Average of 20 days

Study Arms (2)

Endovis BA2 Nail

EXPERIMENTAL

The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments. The system has been designed to allow: * stable fracture synthesis for fast rehabilitation and early mobilization * an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps) This is a one off surgical fixation.

Device: Endovis BA2 nail

Dynamic Hip Screw (DHS)

ACTIVE COMPARATOR

The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation. This Dynamic Hip Screw method is currently used and is a one off surgical fixation.

Device: Dynamic Hip Screw (DHS)

Interventions

Endovis BA2 nail DEVICE

The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments. The system has been designed to allow: * stable fracture synthesis for fast rehabilitation and early mobilization * an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps)

Endovis BA2 Nail

Dynamic Hip Screw (DHS) DEVICE

The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation. This Dynamic Hip Screw method is currently used and is a one off surgical fixation.

Dynamic Hip Screw (DHS)

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-95 years
• Fresh unstable (AO/OTA type A2) pertrochanteric fracture
• If medically fit, patient will undergo surgical fixation within 48 hours of admission. Otherwise, all patients to be recruited must undergo surgery within 7 days of admission
• Patient or patient's carer/personal or nominated consultee has provided informed consent/assent to participate in the study
• Patient is considered able to complete the study assessment and visit schedule in the opinion of the investigating team

You may not qualify if:

• Unable to ambulate pre-injury, even with walking aids
• Unable to undergo surgical fixation within 7 days of admission
• Patient is for any reason considered unable to carry out the required study assessments or complete the follow-up visit schedule, in the opinion of the investigating team
• Previous stroke (non-recovered)
• Recent myocardial infarction (up to 60 days)
• Presence of fracture(s) in contralateral leg
• Presence of fracture(s) in ipsilateral leg, in addition to the pertrochanteric hip fracture
• Known renal or hepatic failure as defined by:
• Elevated transaminases ≥ 2.0 x upper limits of normal for:
• Serum aspartate aminotransferase (AST)
• Serum alanine aminotransferase (ALT)
• Significantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation21

Sponsors & Collaborators

• University of Leeds: lead
• Citieffe S.r.l: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS9 2LU, United Kingdom

RECRUITING

Study Officials

• Peter Giannoudis, MBBS,CCST,MD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Giannoudis, MBBS,CCST,MD

CONTACT

01133922750; peter.giannoudis@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: June 2, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 22, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)