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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02061904
First Posted: February 13, 2014
Last Update Posted: October 4, 2017
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.
Information provided by (Responsible Party):
Job van Susante, Rijnstate Hospital
  Purpose
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.

Condition Intervention
Disorder of Bone Density and Structure, Unspecified Satisfaction Radiation: DEXA: dual energy X-ray absorptiometry Other: Short Form Health Survey 12 Other: VAS-satisfaction Other: VAS-pain Other: Harris Hip Score

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Exploratory Study:Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting

Resource links provided by NLM:


Further study details as provided by Job van Susante, Rijnstate Hospital:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: January 2014
Study Completion Date: January 2017
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bone Mineral Density measurement
Hip function

Hip Function/mobility development:

Harris Hip Score

Other: Harris Hip Score
questionnaire for hip function monitoring
Other Name: HHS
pain experience
Pain experiences after surgery in the hip joint VAS-pain
Other: VAS-pain
questionnaire for pain monitoring
Other Name: visual analog scale for pain
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 Name: SF12
Intervention Satisfaction
Patients satisfaction development after the intervention VAS-satisfaction
Other: VAS-satisfaction
questionnaire for intervention satisfaction monitoring
Other Name: Visual analoge Scale for satisfaction.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061904


Locations
Netherlands
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800WC
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: J v Susante, MD. PhD Rijnstate Hospital