Skip to main content
OpenTrials
Completed

NCT Number: NCT00658268

Bisphosphonates and Impaction Grafting in Hip Revision

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lund University Hospital

Lund, SE-22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clodronate

Drug

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

Placebo

Drug

10 ml, single dose mixed in bone graft at operation

Primary outcomes

  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 outcomes

  1. Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)

    Time frame: 12-24 months

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2008
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.