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

November 21, 2023 updated by: University of Aarhus

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

Orthopaedic

  1. 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
  2. Neuromuscular or vascular condition in one or the other lower extremity
  3. Immobilization postoperative for long periods, for instance because of other serious diseases, alloplasties of the other lower-extremity joint, etc (decided by investigator)
  4. 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
  5. 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
  6. Insufficient RSA marker spread or rigidity Operative
  7. Use of component other than Bimetric femoral stem (HA porous-coated without collar)
  8. Unsuitable bone quality for uncemented hip alloplasty, evaluated preoperatively
  9. 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
  10. Cup placement 10.1 Cup inclination in AP (anteroposterior) plan >56 degrees and <35 degrees as evaluated on roentgenogram Medical
  11. 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.
  12. Arthritis 12.1. rheumatoid arthritis 12.2. psoriasis arthritis 12.3. other arthritides
  13. Metabolic bone disease 13.1. hyperparathyroidism 13.2. Paget bone disease 13.3. renal osteodystrophy 13.4. other
  14. Reduced kidney function thereby influencing bone metabolism
  15. Previous treatment of skeleton with radiation therapy
  16. Cancer Pharmaceuticals
  17. 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
  18. Absent patient compliance with treatment and follow-up investigations
  19. Abuse that the investigator feels would weaken compliance 19.1. alcohol abuse 19.2. medication abuse
  20. Psychological instability (including patient in treatment lithium/antidepressants/neuroleptics/ antipsychotic drugs) which the investigator feels would weaken compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prosthesis, BoneMaster-Exceed cup
Prosthesis, 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)
Device: Prosthesis, BoneMaster-Exceed cup (Biomet)
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
Active Comparator: Prosthesis Exceed cup without HA
Prosthesis Exceed cup without HA: A hemispheric joint cup of the type Exceed cup (Biomet) characterized by a porous surface of titanium plasma spray
Device: Prosthesis Exceed cup without HA (Biomet)
Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA)
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Reoperation of affected hips
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
Postoperative complications (up to 5 years)
Time Frame: End of study
End of study
HOOS (Hip disability and osteoarthritis outcome score)
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
OHS (Oxford Hip Score)
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
HHS (Harris Hip Score) on Range Of Motion (ROM)
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
VAS (Visual Analog Scale) at rest and load
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
EQ-5D (EuroQol)
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)
Radiologic osteolysis
Time Frame: End of study (up to 5 years)
End of study (up to 5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Biomet Denmark Aps
Project coordinator Orthopaedic Centre, Aarhus

Investigators

  • Study Chair: Kjeld Soballe, Prof, dr med, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimated)

December 8, 2014

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110224

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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