AzTrials
AzTrials

OsteoarthritisNCT02311179

The Effect of Implant Coating (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup

A study testing Prosthesis, BoneMaster-Exceed cup (Biomet) and Prosthesis Exceed cup without HA (Biomet) in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Osteoarthritis
What is being tested?
Prosthesis, BoneMaster-Exceed cup (Biomet) and Prosthesis Exceed cup without HA (Biomet)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteDenmark
Study dates
Jan 2013to Aug 2024
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 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic radiographic osteoarthritis
  • Radiographically and clinically adequate bone quality with regard to a total hip prosthesis, including osteoporosis-Dexa-Scanning verification.
  • Age 55 to 75 years
  • Informed written consent

Who cannot join

  • Orthopaedic
  • Other disease of affected hip than primary coxarthrosis at time of inclusion 1.1. Secondary osteoarthritis 1.1.1. sequelae after acetabular fracture 1.1.2. hip-near femoral fracture 1.1.3. calve perthe 1.1.4. dysplasia (severe) 1.1.5. other 1.2 Atraumatic caput necrosis
  • Neuromuscular or vascular condition in one or the other lower extremity
  • Immobilization postoperative for long periods, for instance because of other serious diseases, alloplasties of the other lower-extremity joint, etc (decided by investigator)
  • Reoperation of affected hip because of 4.1 luxation (with closed or open reduction) 4.2 deep infection 4.3 fracture 4.4 aseptic loosening 4.5 other
  • Body Mass Index (BMI) at time of inclusion 81-84 5.1 ≥ 35 kg/m2 (grade 2+3 85, Obese Class I 81) 5.2 < 18,5 kg/m2 81-84
Show all 21Show fewer
  • Insufficient RSA marker spread or rigidity Operative
  • Use of component other than Bimetric femoral stem (HA porous-coated without collar)
  • Unsuitable bone quality for uncemented hip alloplasty, evaluated preoperatively
  • Complications peroperatively on insertion of hip alloplasty that necessitate deviation for the described operative procedure (see section: "Operative procedure"), among others 9.1 per- and postoperative fracture 9.2 bone graft used peroperatively (treatment of bone defects, cysts, etc.) 9.3 screw fixation of the acetabulum 9.4 gluteal detachment or extensive femoral exposure 9.5 trochanter osteotomy 9.6 Under-reaming 1-2 mm (cup size is one mm larger than the reamer, i.e. reaming 51 mm, cup 52 mm) 9.7 Other Radiographic
  • Cup placement 10.1 Cup inclination in AP (anteroposterior) plan >56 degrees and <35 degrees as evaluated on roentgenogram Medical
  • Osteoporosis 11.1. previously diagnosed 11.2. project-related preoperative DEXA (dual energy x-ray absorptiometry ) scan Patients with osteoporosis on the scan (T-score < -2.5) are excluded from the study with referral to medical osteoporosis treatment. Patients with osteopenia (T-score < -1) are included in the project with referral to osteoporosis prophylactic treatment. Patients with osteopenia at project inclusion are DEXA re-scanned at the 2 year follow up.
  • Arthritis 12.1. rheumatoid arthritis 12.2. psoriasis arthritis 12.3. other arthritides
  • Metabolic bone disease 13.1. hyperparathyroidism 13.2. Paget bone disease 13.3. renal osteodystrophy 13.4. other
  • Reduced kidney function thereby influencing bone metabolism
  • Previous treatment of skeleton with radiation therapy
  • Cancer Pharmaceuticals
  • Pharmaceuticals that effect calcium-phosphorus metabolism and bone density 87-98, either through intermittent administration or as a constant dose 17.1. glucocorticoids (systemic) beyond short-term treatment (<5 days) 17.2. immunosuppression/modulation (cyclosporine, methotrexate, etc.) Compliance related
  • Absent patient compliance with treatment and follow-up investigations
  • Abuse that the investigator feels would weaken compliance 19.1. alcohol abuse 19.2. medication abuse
  • Psychological instability (including patient in treatment lithium/antidepressants/neuroleptics/ antipsychotic drugs) which the investigator feels would weaken compliance

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

About this study

Official title: The Effect of Implant Coating With Hydroxyapatite Deposited Electrochemically (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.

Read the detailed description

This study focuses on the effect of the hydroxyapatite coating with BoneMaster on the fixation of the hip prosthesis in primary hip alloplasty. A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray is used. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite. A 5-year radiologic analysis of migration will be carried out with the object of detecting prognostic evidence of prosthesis loosening. Migration is determined by Roentgen Stereo-photogrammetric Analysis (RSA) on stereoroentgenography. Simultaneously, the patients will be monitored by using the clinical outcome measure HOOS (Hip disability and osteoarthritis outcome score), OHS (Oxford Hip Score), EQ-5D (EuroQol), HHS (Harris Hip Score) on range of motion, VAS (Visual Analog Scale), postoperative complications and reoperation.

Hypothesis: We expect that the Exceed cup with hydroxyapatite deposited electrochemically (BoneMaster) is superior or equal compared to a similar cup without hydroxyapatite regarding

  • mechanical stability (RSA)
  • (clinical outcome)
Conditions
Osteoarthritis
Being tested
Prosthesis, BoneMaster-Exceed cup (Biomet), Prosthesis Exceed cup without HA (Biomet)
Keywords
Prosthesis fixation, hip arthroplasty
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prosthesis, BoneMaster-Exceed cup (Biomet)Device

    Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.

  • Prosthesis Exceed cup without HA (Biomet)Device

    Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.

Study groups in NCT02311179
Study groupRoleWhat they receive
Prosthesis, BoneMaster-Exceed cupActive comparatorProsthesis, BoneMaster-Exceed cup: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster)
Receives: Device: Prosthesis, BoneMaster-Exceed cup (Biomet)
Prosthesis Exceed cup without HAActive comparatorProsthesis Exceed cup without HA: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray
Receives: Device: Prosthesis Exceed cup without HA (Biomet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA)

    Measured: End of study (up to 5 years)

Secondary outcomes (8)

  1. Reoperation of affected hips

    Measured: End of study (up to 5 years)

  2. Postoperative complications (up to 5 years)

    Measured: End of study

  3. HOOS (Hip disability and osteoarthritis outcome score)

    Measured: End of study (up to 5 years)

  4. OHS (Oxford Hip Score)

    Measured: End of study (up to 5 years)

  5. HHS (Harris Hip Score) on Range Of Motion (ROM)

    Measured: End of study (up to 5 years)

  6. VAS (Visual Analog Scale) at rest and load

    Measured: End of study (up to 5 years)

  7. EQ-5D (EuroQol)

    Measured: End of study (up to 5 years)

  8. Radiologic osteolysis

    Measured: End of study (up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2014 (estimated)
  2. Study startJan 2013
  3. Primary completionMar 2015
  4. Study completionAug 2024 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02311179
Sponsor's protocol ID
M-20110224
Status last verified
Dec 2022
First submitted
6 Nov 2012
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.

    PubMed 36422666

Questions about this trial

What is this clinical trial studying?

A study testing Prosthesis, BoneMaster-Exceed cup (Biomet) and Prosthesis Exceed cup without HA (Biomet) in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.

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 4 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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 Denmark. 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?

Results are not available in the source record.

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?

Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA) (time frame: End of study (up to 5 years)). 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 NCT02311179, which also lists 1 linked publication.

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 22 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in