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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Rijnstate Hospital
Sponsor:
Information provided by (Responsible Party):
Job van Susante, Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT02061904
First received: February 9, 2014
Last updated: February 11, 2014
Last verified: February 2014
  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: 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 Rijnstate Hospital:

Primary Outcome Measures:
  • Bone mineral density changes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02061904

Contacts
Contact: Davey Gerhardt, MD 0031653341950 dgerhardt@rijnstate.nl

Locations
Netherlands
Rijnstate Hospital Recruiting
Arnhem, Gelderland, Netherlands, 6800WC
Contact: D.Gerhardt Gerhardt, MD    0031653341950    dgerhardt@rijnstate.nl   
Sub-Investigator: Davey Gerhardt, MD         
Principal Investigator: Job van Susante, MD, PhD         
Sponsors and Collaborators
Rijnstate Hospital
Investigators
Principal Investigator: J v Susante, MD. PhD Rijnstate Hospital
  More Information

Publications:
Responsible Party: Job van Susante, MD, PhD, Rijnstate Hospital
ClinicalTrials.gov Identifier: NCT02061904     History of Changes
Other Study ID Numbers: BMD&BIG
Study First Received: February 9, 2014
Last Updated: February 11, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014