NCT00621088

Brief Summary

This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures). Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration 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

February 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1.1 years

First QC Date

February 11, 2008

Last Update Submit

September 12, 2010

Conditions

Trochanteric and Subtrochanteric Hip FracturesTreatment With a New Nail or a Sliding Hip Screw

Outcome Measures

Primary Outcomes (1)

  • Early postoperative pain (VAS)(and functional mobility (TUG-test))

    1 week postoperative

Secondary Outcomes (1)

  • Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop.

    1 year follow up

Study Arms (1)

Intertan

ACTIVE COMPARATOR
Procedure: Intertan

Interventions

IntertanPROCEDURE

Operations performed either with a Sliding Hip Screw or a nail (Intertan)

Intertan

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.

You may not qualify if:

  • Patients with pathologic fractures, patients already included with a fracture on the opposite side.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic dep, Haukeland University Hospital

Bergen, 5021, Norway

Location

Study Officials

  • Kjell Matre, MD

    Orthopaedic Department, Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 22, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

NO(1)