Bisphosphonates and Impaction Grafting in Hip Revision

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Region Skane.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00658268
First received: April 9, 2008
Last updated: January 26, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Aseptic Loosening of the Hip Prosthesis
Drug: Clodronate
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion) [ Time Frame: 12-24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: March 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Clodronate
60 mg/ml, 10 ml, single dose mixed in bone graft at operation
Other Name: Clodronate
Placebo Comparator: 2 Drug: Placebo
10 ml, single dose mixed in bone graft at operation
Other Name: placebo

Detailed Description:

Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.

We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658268

Contacts
Contact: Magnus Tagil, MD, PhD 46-46-171-501 magnus.tagil@med.lu.se

Locations
Sweden
Lund University Hospital Recruiting
Lund, Sweden, SE-22185
Contact: Magnus Tagil, MD, PhD    46-46-171-000    magnus.tagil@med.lu.se   
Principal Investigator: Magnus Tagil, MD,PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Magnus Tagil, MD, PhD Department of Orthopaedics, Lund University Hospital,Lund, Sweden
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT00658268     History of Changes
Other Study ID Numbers: NKOISR10001, EudraCT2006-006439-39
Study First Received: April 9, 2008
Last Updated: January 26, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
Surgical procedures operative
Prosthesis implantation
Arthroplasty replacement

Additional relevant MeSH terms:
Clodronic Acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014