Bisphosphonates and Impaction Grafting in Hip Revision

NCT ID: NCT00658268

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2017-08-01

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.

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.

Conditions

Aseptic Loosening of the Hip Prosthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

Clodronate

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

10 ml, single dose mixed in bone graft at operation

Interventions

Clodronate

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

Intervention Type: DRUG

Placebo

10 ml, single dose mixed in bone graft at operation

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus Tagil, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedics, Lund University Hospital,Lund, Sweden

Locations

Lund University Hospital

Lund, , Sweden

Countries

Sweden

Other Identifiers

EudraCT2006-006439-39

Identifier Type: -

Identifier Source: secondary_id

NKOISR10001

Identifier Type: -

Identifier Source: org_study_id