NCT00837850

Brief Summary

A randomised radiostereometric study comparing SmartSet HV and Palacos R acrylic bone cements.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

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 1, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

February 4, 2009

Last Update Submit

August 25, 2011

Conditions

Arthritis

Keywords

total hip arthroplastyCharnley stemRSAnon-inflammatory arthritis

Outcome Measures

Primary Outcomes (1)

  • Distal migration of the charnley femoral stem

    2010

Secondary Outcomes (1)

  • Rotational movements of the charnley femoral stem

    2010

Study Arms (2)

1

ACTIVE COMPARATOR
Device: Bone cement 1

2

ACTIVE COMPARATOR
Device: Bone cement 2

Interventions

Bone cement 1DEVICE

Bone cement SmartSet® HV

Also known as: SmartSet HV
1
Bone cement 2DEVICE

Bone cement Palacos R

Also known as: Palacos R
2

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients in need for total hip arthroplasty

You may not qualify if:

  • patients with an existing condition such as malignancy, pregnancy, severe osteoporosis and disabling musculoskeletal problems (other than in the hips),
  • patients on corticosteroid treatment,
  • patients who had already participated in a clinical study with an investigational product in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Husby OS, Haugan K, Benum P, Foss OA. A prospective randomised radiostereometric analysis trial of SmartSet HV and Palacos R bone cements in primary total hip arthroplasty. J Orthop Traumatol. 2010 Mar;11(1):29-35. doi: 10.1007/s10195-010-0087-x. Epub 2010 Mar 3.

    PMID: 20198403RESULT

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Otto S. Husby, PhD

    St.Olavs hospital HF

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

October 1, 2002

Primary Completion

October 1, 2003

Study Completion

October 1, 2008

Last Updated

August 26, 2011

Record last verified: 2011-08