NCT00658268

Brief Summary

The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

9.4 years

First QC Date

April 9, 2008

Last Update Submit

August 11, 2017

Conditions

Aseptic Loosening of the Hip Prosthesis

Keywords

Surgical procedures operativeProsthesis implantationArthroplasty replacement

Outcome Measures

Primary Outcomes (1)

  • Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)

    12 months

Secondary Outcomes (1)

  • Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)

    12-24 months

Study Arms (2)

1

EXPERIMENTAL
Drug: Clodronate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ClodronateDRUG

60 mg/ml, 10 ml, single dose mixed in bone graft at operation

1
PlaceboDRUG

10 ml, single dose mixed in bone graft at operation

2

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique
  • Obtained informed consent
  • Pregnancy excluded in women of childbearing age

You may not qualify if:

  • Patients with known renal disease or S-creatinine \>175 mcmol/L
  • Patients with S-calcium 2.75 mmol/L
  • Patients with diagnosed Rheumatoid arthritis
  • Patients with active primary hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, SE-22185, Sweden

Location

MeSH Terms

Interventions

Clodronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Magnus Tagil, MD, PhD

    Department of Orthopaedics, Lund University Hospital,Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2008

First Posted

April 14, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

SE(1)