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Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02154516
Recruitment Status : Active, not recruiting
First Posted : June 3, 2014
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew, Inc.

Brief Summary:
The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Condition or disease Intervention/treatment Phase
Arthritis, Degenerative Device: ODH Hip System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group
Actual Study Start Date : November 4, 2011
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control Total Hip Replacement Device

Total Hip replacement surgery using control device consisting of a hard-on-soft bearing or a ceramic-on-ceramic bearing which includes:

  • R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
  • OXINIUM heads on polyethylene liners or
  • Ceramic heads on ceramic liners (all uncemented components)
Device: ODH Hip System
Other Names:
  • Total Hip Replacement
  • THR
  • Total Hip Arthroplasty
  • THA

Experimental: Investigational Hard-on-Hard Total Hip Replacement Device

Total Hip replacement surgery using an experimental device consisting of a hard-on-hard bearing which includes:

  • R3 acetabular cup, and an uncemented SYNERGY or ANTHOLOGY femoral stem
  • R3 ODH acetabular cup liners (sizes 38/50, 40/52, 42/54 and 44/56 mm)
  • R3 ODH femoral heads (sizes 38, 40, 42 and 44 mm)
  • Taper sleeves Ti -6AL-4V (sizes -4, +0, +4, and +8)
Device: ODH Hip System
Other Names:
  • Total Hip Replacement
  • THR
  • Total Hip Arthroplasty
  • THA




Primary Outcome Measures :
  1. Revision Rate [ Time Frame: Up to 10 Years ]
    Reoperations that led to removal or replacement of any of the acetabular or femoral components.

  2. Adverse Events [ Time Frame: Up to 10 Years ]
  3. Metal Ion Concentration in Whole Blood [ Time Frame: Up to 10 years ]

Secondary Outcome Measures :
  1. Harris Hip score [ Time Frame: Up to 10 years ]
  2. Hip Disability and Osteoarthritis Outcome Scores (HOOS) [ Time Frame: Up to 10 years ]
  3. Radiographic measures [ Time Frame: Up to 10 years ]
    Assessment of bone loss, radiolucencies, subsidence, and heterotopic ossification

  4. Health economic outcomes-Surgical blood loss [ Time Frame: Intra-operative ]
    Measured in ml blood

  5. Health economic outcomes -Length of hospital stay [ Time Frame: Hospital admission to discharge ]
    Measure of days spent in hospital

  6. Health economic outcomes-Operative time [ Time Frame: Intra-operative ]
    Operative time - first incision into skin to time when last suture is applied

  7. Health economic outcomes - Re-hospitalisations [ Time Frame: Up to 10 years ]
    Re-hospitalisations-number of re-admissions to hospital



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 21 years old
  • Skeletally mature
  • Requires primary, unilateral total hip arthroplasty due to degenerative join disease
  • Preoperative Harris Hip Score of less than or equal to 70
  • Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
  • Given consent to participate in the study
  • Able to understand the purpose of the study, his/her role, and is available for follow-up

    10 year extension:

    • Subject has completed the 2 year primary study
    • Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
    • Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion Criteria:

  • Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
  • Requires bilateral THA
  • Requires revision of a prior hip replacement
  • Active infection or sepsis
  • History of local hip infection
  • Known metastatic or neoplastic disease
  • Conditions that may interfere with THA survival or outcomes
  • Need for structural bone grafts to support the implant
  • Contralateral lower extremity condition
  • Has other joint replacements or plans for other joint replacements within 2 years
  • Systemic steroid therapy within 3 months prior to surgery
  • Life expectancy less than 2 years
  • Intra-articular therapy within 6 months of enrollment
  • Female of child-bearing age not using contraception
  • Inadequate bone stock to support the device
  • Moderate to severe renal insufficiency
  • Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
  • BMI >40
  • Above the knee amputation of the contralateral or ipsilateral leg
  • Known allergies to the components of the devices
  • Entered into another investigational study
  • Is a prisoner

    10 year extension:

    • In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.


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): NCT02154516


Locations
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South Africa
Entabeni Hospital
Durban, South Africa, 4001
Zuid Afrikaans Hospital
Pretoria, South Africa, 0002
Sponsors and Collaborators
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Andrew Baker Entabeni Hospital
Principal Investigator: Johannes de Beer Zuid Afrikaans Hospital

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Responsible Party: Smith & Nephew, Inc.
ClinicalTrials.gov Identifier: NCT02154516     History of Changes
Other Study ID Numbers: 2011-ODHH166
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases