Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting
Condition: Disorder of Bone Density and Structure, Unspecified; Satisfaction
MeSH terms: Bone Diseases
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): DEXA: dual energy X-ray absorptiometry; Short Form Health Survey 12; VAS-satisfaction; VAS-pain; Harris Hip Score
Intervention type(s): Radiation; Other; Other; Other; Other
Intervention description(s): Bone mineral density development measured with dual energy X-ray absorptiometry; questionnaire for general health monitoring; questionnaire for intervention satisfaction monitoring; questionnaire for pain monitoring; questionnaire for hip function monitoring
Other intervention name(s): Bone Mineral Density measurement; SF12; Visual analoge Scale for satisfaction.; visual analog scale for pain; HHS
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic