Bisphosphonates and Impaction Grafting in Hip Revision

Region Skane

Status and phase: Completed; Phase 2

Conditions: Aseptic Loosening of the Hip Prosthesis

Treatments: Drug: Placebo; Drug: Clodronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00658268

NKOISR10001

EudraCT2006-006439-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Clodronate

2

Placebo Comparator group

Treatment:

Drug: Placebo