Bisphosphonates and Impaction Grafting in Hip Revision

Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.

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.

Study Overview

• Status: Completed
• Conditions: Aseptic Loosening of the Hip Prosthesis
• Intervention / Treatment: Drug: Clodronate; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-22185
    • Lund University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; 10 ml, single dose mixed in bone graft at operation
EXPERIMENTAL: 1	Drug: Clodronate; 60 mg/ml, 10 ml, single dose mixed in bone graft at operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)	12-24 months

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Magnus Tagil, MD, PhD, Department of Orthopaedics, Lund University Hospital,Lund, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2008
• Primary Completion (ACTUAL): August 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: April 9, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (ESTIMATE): April 14, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Surgical procedures operative; Prosthesis implantation; Arthroplasty replacement
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Bone Density Conservation Agents; Clodronic Acid
• Other Study ID Numbers: NKOISR10001; EudraCT2006-006439-39