Disorder of Bone Density and Structure, UnspecifiedBMD&BIGNCT02061904
Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting
A study testing DEXA: dual energy X-ray absorptiometry, Short Form Health Survey 12 and VAS-satisfaction in people with Disorder of Bone Density and Structure, Unspecified and Satisfaction, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Disorder of Bone Density and Structure, Unspecified, Satisfaction
- What is being tested?
- DEXA: dual energy X-ray absorptiometry, Short Form Health Survey 12 and VAS-satisfaction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Will bone impaction grafting of the acetabulum result in a well preserved/remodelled bone stock within 2 years after revision hip arthroplasty?
- 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.
- 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.
- Being tested
- DEXA: dual energy X-ray absorptiometry, Short Form Health Survey 12, VAS-satisfaction, VAS-pain, Harris Hip Score
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA: dual energy X-ray absorptiometryRadiation
Also called Bone Mineral Density measurement
Bone mineral density development measured with dual energy X-ray absorptiometry
Short Form Health Survey 12Other
Also called SF12
questionnaire for general health monitoring
VAS-satisfactionOther
Also called Visual analoge Scale for satisfaction.
questionnaire for intervention satisfaction monitoring
VAS-painOther
Also called visual analog scale for pain
questionnaire for pain monitoring
Harris Hip ScoreOther
Also called HHS
questionnaire for hip function monitoring
| Study group | Role | What they receive |
|---|---|---|
| Bone Mineral Density | Other | Bone mineral density measurement with "intervention" DEXA at the bone impaction graft site:
DEXA: dual energy X-ray absorptiometry Receives: Radiation: DEXA: dual energy X-ray absorptiometry |
| Hip function | Other | Hip Function/mobility development:
Harris Hip Score Receives: Other: Harris Hip Score |
| pain experience | Other | Pain experiences after surgery in the hip joint VAS-pain Receives: Other: VAS-pain |
| General Patients Health condition | Other | Patients health condition monitoring: intervention SF12:
Short Form Health Survey 12 Receives: Other: Short Form Health Survey 12 |
| Intervention Satisfaction | Other | Patients satisfaction development after the intervention VAS-satisfaction Receives: Other: VAS-satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disorder of Bone Density and Structure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Job van Susante, Rijnstate Hospital
- Investigators
- J v Susante, MD. PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061904
- Sponsor's protocol ID
- BMD&BIG
- Acronym
- BMD&BIG
- Status last verified
- Oct 2017
- First submitted
- 9 Feb 2014
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23219623Smolders 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.
PubMed 21037344
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Study:Bone Mineral Density Changes of the Acetabulum After Revision Hip Arthroplasty Using Bone Impaction Grafting
- ClinicalTrials.gov ID
- NCT02061904
- Acronym / sponsor ID
- BMD&BIG / BMD&BIG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Will bone impaction grafting of the acetabulum result in a well preserved/remodelled bone stock within 2 years after revision hip arthroplasty?
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Bone Mineral Density | Other | Radiation: DEXA: dual energy X-ray absorptiometryBone mineral density measurement with "intervention" DEXA at the bone impaction graft site: DEXA: dual energy X-ray absorptiometry |
| Hip function | Other | Other: Harris Hip ScoreHip Function/mobility development: Harris Hip Score |
| pain experience | Other | Other: VAS-painPain experiences after surgery in the hip joint VAS-pain |
| General Patients Health condition | Other | Other: Short Form Health Survey 12Patients health condition monitoring: intervention SF12: Short Form Health Survey 12 |
| Intervention Satisfaction | Other | Other: VAS-satisfactionPatients satisfaction development after the intervention VAS-satisfaction |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA: dual energy X-ray absorptiometryAlso: Bone Mineral Density measurementBone mineral density development measured with dual energy X-ray absorptiometry | Radiation | Bone Mineral Density |
| Short Form Health Survey 12Also: SF12questionnaire for general health monitoring | Other | General Patients Health condition |
| VAS-satisfactionAlso: Visual analoge Scale for satisfaction.questionnaire for intervention satisfaction monitoring | Other | Intervention Satisfaction |
| VAS-painAlso: visual analog scale for painquestionnaire for pain monitoring | Other | pain experience |
| Harris Hip ScoreAlso: HHSquestionnaire for hip function monitoring | Other | Hip function |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Background: PubMed 23219623Smolders 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.
- Background: PubMed 21037344Smolders 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J v Susante, MD. PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEXA: dual energy X-ray absorptiometry, Short Form Health Survey 12 and VAS-satisfaction in people with Disorder of Bone Density and Structure, Unspecified and Satisfaction, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density changes (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061904, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.