Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting (BMD&BIG)

October 3, 2017 updated by: Job van Susante, Rijnstate Hospital

Prospective Exploratory Study:Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting

Prospective explorative study for the investigation of short-term and medium-term outcomes regarding bone mineral density changes after revision hip arthroplasty making use of bone impaction grafting. Outcome measurements will include objective and subjective clinical data, complications and adverse events, radiographic data measurements recorded at several postoperative intervals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypothesis, open questions and specific aims of the project:

We believe that it is important to gain further insight in the process of bone graft remodeling and the preservation of bone stock after bone impaction grafting.

Radiographs are far from conclusive and CT scan can not be repeated on regular intervals for obvious reasons. Prospective follow-up of the BMD of the bone impaction area will contribute to our further understanding. There is no literature available on BMD changes in the acetabulum after bone impaction grafting.

From our recent experiences with earlier research on BMD in specific ROI in the femoral neck we are motivated to further explore the potential of our DEXA technology and software in the field revision hip arthroplasty.

We hypothesize that BMD changes in the bone impaction grafted acetabulum can be adequately monitored with modern DEXA techniques.

Research Questions are:

  1. Will bone impaction grafting of the acetabulum result in a well preserved/remodelled bone stock within 2 years after revision hip arthroplasty?

  2. Can changes in BMD be interpreted as representative for the process of bone remodelling in the bone impacted area?

    Study design

    This trial as described in this protocol is a prospective explorative follow-up study recording the clinical, radiographic data, and bone mineral density data at specific time intervals (preoperative, within 2 weeks postoperative, at 3months, 6months, 1 year and 2 years postoperative). The data will be collected using SPSS (version 20.)

    Main objective:

    To prospectively assess the BMD at short and medium time intervals in specific ROI as an indicator for the process of bone remodelling and ossification of the bone impaction graft after revision hip arthroplasty..

    Secondary Objectives:

    Clinical scores (SF-12, Oxford Hip score, VAS pain and VAS satisfaction) will be obtained. Vigilant identification of Adverse Events (AEs) will be maintained throughout the study. Mean changes in clinical scores, over time, will also be tested with repeated measurement statistics. Because clinical success is not always indicative of radiographic success and vice versa, correlations will be made.

    Sample size:

    Our study concerns an explorative study in twenty patients.

    Study duration:

    The expected duration of the study is approximately 3 years from the commencement of subject enrollment. Subject enrollment is expected to take 1 year. All subjects will be followed for at least two years after surgery until the last subject achieves two-years follow-up.

    Evaluation criteria

    The study is designed to evaluate possible clinical, radiographic and bone densitometry differences changes after revision hip arthroplasty.

    Evaluation criteria at different follow-up intervals.

    A Clinical:

    • the patient's own evaluation according to the Oxford Score, Dutch translation validated
    • the patient's evaluation of his general health with the SF-12 score , license to validated Dutch translation11
    • the patient's degree of pain and satisfaction with the prosthesis and the procedure.

    B Radiological:

    • X-ray evaluations of implant stability, migration, changing of cup or head angles, radiolucent lines, loosening and osteolysis. X-Rays should preferably be digital, at preoperative, 6 months, 1 year and 2 years.

    C. DEXA bone density measurements

    - Bone density measurements will be performed preoperative on the acetabulum on several regions of interests (ROI's) including the bone impaction grafting area. Once this ROI's of the acetabulum has been determined it can be digitalized and saved into the software, subsequently this ROI can be transported 4 days postoperative and at 4 days postoperative, 6 months, 1 year and 2 years.

    - This method has been tested in our earlier resurfacing study and has proved to be reliable and reproducable.

    - An independent radiologist will do the measurements on the DEXA-scan

    D Survival after revision hip arthroplasty with bone impaction grafting - According to Kaplan Meiers survival rates.

    E Complications and adverse events

    - Early and late complications possibly associated with revision hip arthroplasty and possible relationship with bone impaction grafting and surgical technique.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6800WC
        • Rijnstate Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. revision hip arthroplasty with acetabular defects eligible for bone impaction grafting
  2. Diagnosis: acetabular osteolytic defects after primary total hip arthroplasty, planned for revision hip arthroplasty with bone impaction grafting.
  3. Patient is between 35 and 75 years old.
  4. Patient is expected to recover completely.
  5. Patient is willing and able to come to follow-up examinations.
  6. Patient has signed an informed consent.

Exclusion Criteria:

  1. Infection of the hip joint or distant infection (may cause hematogenous spread to the implant site)
  2. Hip fractures
  3. Patient is younger than 35 years or older than 75 years.
  4. Patient is not willing and/or able to come to follow-up examinations
  5. Patient has not signed an informed consent
  6. Pregnancy

Relative contra-indications:

With regard to the patient's general health:

  1. Metabolic disorders or medication (e.g. steroids) which may impair bone formation
  2. Osteomalacia
  3. Disorders of the immune system, caused by disease or immunosuppressive medication which increase the risk of infection.
  4. Poor prognosis for good wound healing: decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Bone Mineral Density

Bone mineral density measurement with "intervention" DEXA at the bone impaction graft site:

DEXA: dual energy X-ray absorptiometry
Radiation: DEXA: dual energy X-ray absorptiometry
Bone mineral density development measured with dual energy X-ray absorptiometry
Other Names:
  • Bone Mineral Density measurement
Other: Hip function

Hip Function/mobility development:

Harris Hip Score
Other: Harris Hip Score
questionnaire for hip function monitoring
Other Names:
  • HHS
Other: pain experience
Pain experiences after surgery in the hip joint VAS-pain
Other: VAS-pain
questionnaire for pain monitoring
Other Names:
  • visual analog scale for pain
Other: General Patients Health condition

Patients health condition monitoring: intervention SF12:

Short Form Health Survey 12
Other: Short Form Health Survey 12
questionnaire for general health monitoring
Other Names:
  • SF12
Other: Intervention Satisfaction
Patients satisfaction development after the intervention VAS-satisfaction
Other: VAS-satisfaction
questionnaire for intervention satisfaction monitoring
Other Names:
  • Visual analoge Scale for satisfaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone mineral density changes
Time Frame: 24 months
Acetabular bone mineral density measurements after bone impaction grafting using DEXA, changes in density compared to baseline levels: at < 2weeks postoperative, at 3, 6, 12 and 24 months postoperative
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

  • Principal Investigator: J v Susante, MD. PhD, Rijnstate Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

February 9, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMD&BIG

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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