Comparison of Sliding Hip Screw to Intra Medullary Nailing in the Treatment of Intertrochanteric Hip Fracture

NCT ID: NCT03906032

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-02
• Study Completion Date: 2025-07-02

Brief Summary

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence, gait speed and increased double support time on the injured side.

The use of an IM nail device may reduce shortening and improve functional parameters in this patient cohort

Detailed Description

Published work in this field to date has not demonstrated an advantage of nailing over hip screw in intertrochanteric proximal femoral fractures. The current literature focus on outcome questionnaires, pain scores and basic functional tests alone may not delineate all functional benefits. A key factor in whether a person, post hip fracture, returns to independent living is gait speed. The cost implications on the healthcare provider of having 30% of this ever increasing group losing their independence and requiring admission to a care facility post hip fracture is a growing problem.

Shortening of the abductor lever arm is a particular concern with the SHS, and the resultant biomechanical alterations may impair gait, including decreased cadence and increased double support time on the injured side.

The cost differential between a nail and a SHS is a barrier to routine use of nailing in this population unless a clear benefit is demonstrated. Fracture nonunion is uncommon in this injury however improving functional outcome and reducing morbidity and mortality in this group is important.

In this prospective randomised study, the investigators examine whether an intramedullary nail (TFNA) results in a greater functional benefit in A1/A2 intertrochanteric fractures compared with the SHS, in terms of gait speed and other objective gait assessments, as well as other established post operative outcome measures.

Conditions

Hip Fractures; Gait, Unsteady; Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intra-medullary hip Nail

Surgery

Group Type: EXPERIMENTAL

TFNA IM Nail

Intervention Type: DEVICE

IM nail

Sliding hip screw

Surgery

Group Type: ACTIVE_COMPARATOR

Sliding hip screw

Intervention Type: DEVICE

SHS surgical fixation

Interventions

TFNA IM Nail

IM nail

Intervention Type: DEVICE

Sliding hip screw

SHS surgical fixation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• OTA Hip fracture grade A1 and A2
• Greater than 18 years old

Exclusion Criteria

• Fracture less than 18 yrs old
• Fracture with lateral wall trochanteric comminution
• Poltrauma
• Concurrent lower limb fractures
• Immobile/wheelchair/bedbound patients
• High energy hip fractures
• Pathological fractures
• Reverse oblique and sub-trochanteric femoral fractures which are considered obligate TFNA at our centre
• Open wounds on affected limb
• Active psoriasis or other dermatological conditions at affected area
• Unable to gain consent from patient or patient's NOK

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DePuy Synthes

INDUSTRY

Sponsor Role: collaborator

University Hospital Waterford

OTHER

Sponsor Role: lead

Responsible Party

May Cleary

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Waterford

Waterford, , Ireland

Countries

Ireland

Other Identifiers

UHWHip#

Identifier Type: -

Identifier Source: org_study_id