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Bisphosphonates and Impaction Grafting in Hip Revision

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ClinicalTrials.gov Identifier: NCT00658268
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Aseptic Loosening of the Hip Prosthesis Drug: Clodronate Drug: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Actual Study Start Date : March 2008
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 1, 2017

Arm Intervention/treatment
Experimental: 1 Drug: Clodronate
60 mg/ml, 10 ml, single dose mixed in bone graft at operation
Placebo Comparator: 2 Drug: Placebo
10 ml, single dose mixed in bone graft at operation



Primary Outcome Measures :
  1. Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion) [ Time Frame: 12-24 months ]


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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658268


Locations
Sweden
Lund University Hospital
Lund, Sweden, SE-22185
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Magnus Tagil, MD, PhD Department of Orthopaedics, Lund University Hospital,Lund, Sweden

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT00658268     History of Changes
Other Study ID Numbers: NKOISR10001
EudraCT2006-006439-39
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

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

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