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Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803839
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oulu

Brief Summary:

Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant.

Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing packages were labeled only with the code from the pharmacy of the hospital. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris hip score (HHS).

The purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary THA.


Condition or disease Intervention/treatment Phase
Hip Arthrosis Drug: Clodronate Drug: Saline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In this prospective, double-blinded, randomized, placebo-controlled clinical trial with two years follow-up period the investigators rinsed the proximal intramedullary cavity of the femur with either clodronate (60 mg clodronate in 1000 ml saline) or saline (1000 ml saline) prior to the application of the femoral stem.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients were randomized into two treatment groups; either the clodronate or a placebo group. All patients, surgeons and other personnel in the operating theatre were blinded as to the patients' study group.
Primary Purpose: Treatment
Official Title: Could the Intra-operative Clodronate Rinsing Improve the Integration of the Femoral Stem in a Prospective, Double-blinded, Randomized, Placebo-controlled Clinical RSA-study
Actual Study Start Date : March 26, 2004
Actual Primary Completion Date : March 12, 2014
Actual Study Completion Date : March 12, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Clodronate
1 mM clodronate (60 mg in 1000 ml saline) was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the clodronate solution. The time for rinsing was about one minute.
Drug: Clodronate
Placebo Comparator: Saline
1000 ml saline was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the saline solution. The time for rinsing was about one minute.
Drug: Saline



Primary Outcome Measures :
  1. Maximal total point motion (MTPM) - migration of the femoral stem [ Time Frame: 0 to 24 months ]
    It represents the length of the translation vector of the point in a rigid body that has the greatest motion. It can only have positive values, and is not normally distributed. The reason for using MTPM is that in many cases, motion implies a biological effect of some kind and this effect is liable to be greatest at the point of maximum motion. The parameter has been measured by RSA-methods, which is an accurate method of determining the migration and wear of orthopaedic implants: it determine the precise location of two distinct objects relative to each other in three dimension such as the relative position of the femoral component and the proximal femur. In radiostereometric analysis the position in space of the original object is reconstructed from a two dimensional x-ray film using tantalum beads. Movement between segments is then calculated by localizing each segment in a coordinate system. Lower values represent a better outcome.


Secondary Outcome Measures :
  1. Bone mineral density (BMD) in 7 Gruen zones [ Time Frame: 0 to 24 months ]
    BMD was measured by dual-energy X-ray absorptiometry, DXA. In clinical use, precision errors are < 5 %. To evaluate the horizontal linear distribution of the BMD, seven Gruen zones, peri-prosthetic sub-regions of interest, ROI (region of interest) were calculated by the software on the anteroposterior view of the proximal femur. The value of BMD is g/cm2 and it estimates the strength of the bone. Higher values/lesser decrease in values represent a better outcome.


Other Outcome Measures:
  1. Migration of femoral stem [ Time Frame: 0 to 24 months ]
    Subsidence and vertical movement of the femoral stem (scale micrometers), x-, y- and z-translations. Parameters were measured using RSA-methods and the scaling is linear. Lower values represent a better outcome.

  2. The maximal (MTPM) maximal total point motion [ Time Frame: 3 to 24 months ]
    The maximal MTPM value after 3 months when the expected integration of stem should have happened. Lower values represent a better outcome.

  3. Correlation between baseline BMD and the maximal MTPM [ Time Frame: BMD (0 month) - the maximal MTPM 3 to 24 months ]
    This parameters summarize the BMD and RSA values together. The investigators have planned it to evaluate the correlation between the quality of periprosthetic bone in baseline and the migration of femoral stem during 2 years follow-up period between the study groups.

  4. Harris Hip Score (HHS) [ Time Frame: 0 to 24 months ]
    Harris Hip Score (HHS) is a clinician-based outcome measure, health status scale, that is frequently used to measure the outcome of total hip arthroplasty. It is measured by questionnaire that give points from 0 to 100. Higher values represent a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 73 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip arthrosis and
  • a primary THA was planned

Exclusion Criteria:

  • renal insufficiency
  • hypercalcemia
  • malignant tumors
  • contemporaneously treatment with another bisphosphonate or aminoglycoside
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT03803839    
Other Study ID Numbers: Ei tiedossa
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome data will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available after submitting the results to the scientific journals and five years after the publication.
Access Criteria: Data Access requests will be reviewed By an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oulu:
RSA
DXA
Bisphosphonates
Migration of stem
Aseptic loosening of prosthesis
Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis, Hip
Musculoskeletal Diseases
Osteoarthritis
Arthritis
Rheumatic Diseases
Clodronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs