Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting

NCT02061904 | Completed

• 1 other identifier: BMD&BIG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Disorder of Bone Density and Structure, Unspecified; Satisfaction

Outcome Measures

Primary Outcomes (1)

• Bone mineral density changes

  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

Study Arms (5)

Bone Mineral Density

OTHER

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

Hip function

OTHER

Hip Function/mobility development: Harris Hip Score

Other: Harris Hip Score

pain experience

OTHER

Pain experiences after surgery in the hip joint VAS-pain

Other: VAS-pain

General Patients Health condition

OTHER

Patients health condition monitoring: intervention SF12: Short Form Health Survey 12

Other: Short Form Health Survey 12

Intervention Satisfaction

OTHER

Patients satisfaction development after the intervention VAS-satisfaction

Other: VAS-satisfaction

Interventions

DEXA: dual energy X-ray absorptiometry RADIATION

Bone mineral density development measured with dual energy X-ray absorptiometry

Also known as: Bone Mineral Density measurement

Bone Mineral Density

Short Form Health Survey 12 OTHER

questionnaire for general health monitoring

Also known as: SF12

General Patients Health condition

VAS-satisfaction OTHER

questionnaire for intervention satisfaction monitoring

Also known as: Visual analoge Scale for satisfaction.

Intervention Satisfaction

VAS-pain OTHER

questionnaire for pain monitoring

Also known as: visual analog scale for pain

pain experience

Harris Hip Score OTHER

questionnaire for hip function monitoring

Also known as: HHS

Hip function

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Infection of the hip joint or distant infection (may cause hematogenous spread to the implant site)
• Hip fractures
• Patient is younger than 35 years or older than 75 years.
• Patient is not willing and/or able to come to follow-up examinations
• Patient has not signed an informed consent
• Pregnancy
• Relative contra-indications:
• With regard to the patient's general health:
• Metabolic disorders or medication (e.g. steroids) which may impair bone formation
• Osteomalacia
• Disorders of the immune system, caused by disease or immunosuppressive medication which increase the risk of infection.
• Poor prognosis for good wound healing: decubitus ulcer, end-stage diabetes, severe protein deficiency and/or malnutrition

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6800WC, Netherlands

Location

Related Publications (2)

• Smolders JM, Pakvis DF, Hendrickx BW, Verdonschot N, van Susante JL. Periacetabular bone mineral density changes after resurfacing hip arthroplasty versus conventional total hip arthroplasty. A randomized controlled DEXA study. J Arthroplasty. 2013 Aug;28(7):1177-84. doi: 10.1016/j.arth.2012.08.025. Epub 2012 Dec 6.

  PMID: 23219623 BACKGROUND

• Smolders JM, Hol A, Rijnders T, van Susante JL. Changes in bone mineral density in the proximal femur after hip resurfacing and uncemented total hip replacement: A prospective randomised controlled study. J Bone Joint Surg Br. 2010 Nov;92(11):1509-14. doi: 10.1302/0301-620X.92B11.24785.

  PMID: 21037344 BACKGROUND

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• J v Susante, MD. PhD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 9, 2014
• First Posted: February 13, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

NL (1)