NCT06689579

Brief Summary

The purpose of this study is to determine whether significant functional benefits are seen in patients who have a bipolar hemiarthroplasty as treatment for hip fracture compared to those who have a unipolar hemiarthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_4

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

October 14, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
5.4 years until next milestone

First Posted

Study publicly available on registry

November 14, 2024

Completed
Last Updated

November 14, 2024

Status Verified

September 1, 2024

Enrollment Period

4.7 years

First QC Date

March 21, 2016

Last Update Submit

November 13, 2024

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Pain

    visual analogue scale pain score ( on a 10cm baseline fro 'no pain' to 'worst pain imaginable'

    1 year

Secondary Outcomes (20)

  • Pain

    2 years

  • Function

    1 year

  • Radiographic assessment

    1 year

  • Complications

    intraoperative

  • Function

    1 year

  • +15 more secondary outcomes

Study Arms (2)

Unipolar

EXPERIMENTAL

Unipolar hemiarthroplasty used for treatment of intracapsular hip fracture

Device: Unipolar hemiarthroplasty

Bipolar

ACTIVE COMPARATOR

Bipolar hemiarthroplasty used for treatment of intracapsular hip fracture

Device: Bipolar hemiarthroplasty

Interventions

Unipolar hemiarthroplastyDEVICE
Also known as: C Stem AMT Unipolar Hemi Arthroplasty DePuy Synthes
Unipolar
Bipolar hemiarthroplastyDEVICE
Also known as: C Stem AMT Bipolar Hemi Arthroplasty DePuy Synthes
Bipolar

Eligibility Criteria

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

You may qualify if:

  • Patients admitted with an intracapsular fracture of the femoral neck who are suitable for a hemiarthroplasty.

You may not qualify if:

  • Patients deemed suitable for a total hip arthroplasty, patients with a high energy fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary Edinburgh

Edinburgh, Lothian, EH164SA, United Kingdom

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Leela Biant, MD, MBBS

    NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

November 14, 2024

Study Start

October 14, 2014

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

November 14, 2024

Record last verified: 2024-09

Locations

GB(1)