NCT00756431

Brief Summary

Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Status
withdrawn

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

January 1, 2004

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

6.4 years

First QC Date

September 19, 2008

Last Update Submit

June 16, 2017

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Harris Hip Score

    3months, 6 months

Secondary Outcomes (3)

  • DEXA

    3months, 6 months

  • RSA

    3months,6 months

  • Complications

    Anytime

Study Arms (2)

Screw without HA Coating (Hiploc)

ACTIVE COMPARATOR
Device: Hip Fracture reduction Screw without HA Coating (Hiploc)

Screw with HA Coating (Hiploc)

EXPERIMENTAL
Device: Hip Fracture reduction Screw with HA Coating (Hiploc)

Interventions

Hip Fracture reduction Screw without HA Coating (Hiploc)DEVICE

Hip Fracture reduction Screw without HA Coating (Hiploc)

Also known as: Hiploc
Screw without HA Coating (Hiploc)
Hip Fracture reduction Screw with HA Coating (Hiploc)DEVICE

Hip Fracture reduction Screw with HA Coating (Hiploc)

Also known as: Hiploc
Screw with HA Coating (Hiploc)

Eligibility Criteria

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

You may qualify if:

  • Patients with trochanteric femoral fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hendrik Palm, MD

    Hvidovre Univ. Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

January 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 19, 2017

Record last verified: 2017-06