Bisphosphonates and Impaction Grafting in Hip Revision

2014-08-27 03:31:23 | BioPortfolio


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.


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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Aseptic Loosening of the Hip Prosthesis


Clodronate, Placebo


Lund University Hospital




Lund University Hospital

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:31:23-0400

Clinical Trials [236 Associated Clinical Trials listed on BioPortfolio]

Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation

Both HA coated and certain uncoated stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, da...

Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer

RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combin...

Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as refe...

Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement

The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for m...

CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling...

PubMed Articles [1262 Associated PubMed Articles listed on BioPortfolio]

The inhibition of RANKL expression in fibroblasts attenuate CoCr particles induced aseptic prosthesis loosening via the MyD88-independent TLR signaling pathway.

Periprosthetic osteolysis and aseptic loosening are mainly caused by wear particles (Ps) that are generated from friction interfaces. However, the mechanisms underlying the development of aseptic loos...

Osseointegration click-on prosthesis following leg amputation.

Since its introduction in 2009, more than 150 people in the Netherlands have received an osseointegration prosthesis following leg amputation. Serious complications such as septic or aseptic loosening...

Do Stem Design and Surgical Approach Influence Early Aseptic Loosening in Cementless THA?

Some studies have revealed an increased risk of early aseptic loosening of cementless stems in THA when inserted through an anterior or anterolateral approach compared with a posterior approach, where...

Particle-induced SIRT1 downregulation promotes osteoclastogenesis and osteolysis through ER stress regulation.

Sirtuin 1 (SIRT1) downregulation has been found to be induced by wear particles in aseptic prosthesis loosening (APL). Osteoclastogenesis and osteoclast activation are the main pathological factors as...

Clodronate improves lameness in horses without changing bone turnover markers.

Clodronate is prescribed to performance horses with lameness. Despite its clinical popularity, little research has been done to understand the effects of clodronate in the horse.

Medical and Biotech [MESH] Definitions

Malfunction of implantation shunts, valves, etc., and prosthesis loosening, migration, and breaking.

A species of ENTEROVIRUS associated with outbreaks of aseptic meningitis (MENINGITIS, ASEPTIC).

A prosthetic appliance for the replacement of areas of the maxilla, mandible, and face, missing as a result of deformity, disease, injury, or surgery. When the prosthesis replaces portions of the mandible only, it is referred to as MANDIBULAR PROSTHESIS.

The plan and delineation of prostheses in general or a specific prosthesis.

Holding a PROSTHESIS in place.

More From BioPortfolio on "Bisphosphonates and Impaction Grafting in Hip Revision"

Quick Search


Relevant Topics

Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...

Arthroplasty Joint Disorders Orthopedics Spinal Cord Disorders Orthopedics is the science or practice of correcting deformities caused by disease or damage to the bones and joints of the skeleton. This specialized branch of surgery may ...

Arthroplasty is a surgical procedure to restore the integrity and function of a joint. A joint can be restored by resurfacing the bones. An artificial joint (called a prosthesis) may also be used. Various types of arthritis may affect the joints. Osteo...

Searches Linking to this Trial