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

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ClinicalTrials.gov Identifier: NCT02311179
Recruitment Status : Unknown
Verified July 2018 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
Biomet Denmark Aps
Project coordinator Orthopaedic Centre, Aarhus
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief 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. The surface is coated with hydroxyapatite deposited electrochemically (BoneMaster) and will be compared with an identical cup without hydroxyapatite.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Prosthesis, BoneMaster-Exceed cup (Biomet) Device: Prosthesis Exceed cup without HA (Biomet) Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Implant Coating With Hydroxyapatite Deposited Electrochemically (BoneMaster) on Migration and Clinical Outcome in Hip Arthroplasty With the Exceed Cup
Study Start Date : January 2013
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

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.




Primary Outcome Measures :
  1. Radiographic: Migration of the acetabular component (mm, degree) with Model-Based RSA (m-RSA) [ Time Frame: End of study (up to 5 years) ]

Secondary Outcome Measures :
  1. Reoperation of affected hips [ Time Frame: End of study (up to 5 years) ]
  2. Postoperative complications (up to 5 years) [ Time Frame: End of study ]
  3. HOOS (Hip disability and osteoarthritis outcome score) [ Time Frame: End of study (up to 5 years) ]
  4. OHS (Oxford Hip Score) [ Time Frame: End of study (up to 5 years) ]
  5. HHS (Harris Hip Score) on Range Of Motion (ROM) [ Time Frame: End of study (up to 5 years) ]
  6. VAS (Visual Analog Scale) at rest and load [ Time Frame: End of study (up to 5 years) ]
  7. EQ-5D (EuroQol) [ Time Frame: End of study (up to 5 years) ]
  8. Radiologic osteolysis [ Time Frame: End of study (up to 5 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311179


Locations
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Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Biomet Denmark Aps
Project coordinator Orthopaedic Centre, Aarhus
Aarhus University Hospital
Investigators
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Study Chair: Kjeld Soballe, Prof, dr med Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02311179    
Other Study ID Numbers: M-20110224
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Keywords provided by University of Aarhus:
Prosthesis fixation
hip arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors