NCT01745276

Brief Summary

The purpose of this study is to evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

May 23, 2012

Last Update Submit

September 10, 2018

Conditions

Osteoarthritis

Keywords

Pin fixationOsteotomyhemicallotasis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the relative osseomechanical strength of a novel coated pin/screw in a clinical mode.

    To evaluate the relative osseomechanical strength of a novel coated pin/screw

    2011-07-01-2012-02-01

Study Arms (2)

External pins coated by biphosfonate.

EXPERIMENTAL

External pins coated by biphosfonate.

Device: Biphosfonate

External pins coated by hydroxylapatite.

ACTIVE COMPARATOR

External pins coated by hydroxylapatite.

Device: Hydroxylapatit

Interventions

BiphosfonateDEVICE

External pins coated by biphosfonate.

External pins coated by biphosfonate.
HydroxylapatitDEVICE

External pins coated by Hydroxylapatit.

External pins coated by hydroxylapatite.

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients which are diagnosed with arthr and needs an operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopeadic Clinic Hospital

Hässleholm, 28125, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

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

Study Record Dates

First Submitted

May 23, 2012

First Posted

December 10, 2012

Study Start

April 1, 2011

Primary Completion

November 1, 2012

Study Completion

February 1, 2013

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

SE(1)