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Prospective Evaluation of Fixation of the Prime Acetabular Cup

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ClinicalTrials.gov Identifier: NCT04039984
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Douglas Naudie, Lawson Health Research Institute

Brief Summary:
This is a prospective study to compare migration of the Microport Prime acetabular cup to a well-established acetabular cup design after total hip replacement. We will enroll 30 patients with the Prime cup and compare migration, function, pain and quality of life to a historical cohort of patients whom had a different cup used during surgery.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Prime Cup Not Applicable

Detailed Description:

The gold standard for measurement of implant fixation over time is radiostereometric analysis (RSA). At the time of surgery, 0.8-1.0 mm Tantalum beads (typically n = 6-8 per region of interest) are inserted into the bone surrounding the implant of interest, and occasionally also into the polyethylene liner or insert of the implant. RSA exams are then acquired within the first 2 weeks post-operation, and again at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Each exam involves a stereo x-ray acquisition with a calibration unit to reconstruct the 3D location of the implant relative to the marker beads. Across each exam, the migration of the implant relative to the marker beads is tracked compared to the baseline exam acquired within the first 2 weeks. RSA is extremely precise and accurate, and is able to track migrations on the order of 10's of microns. Large early migrations within the first 1-2 years post-operation are predictive of eventual implant loosening and failure. For acetabular cups, proximal migration of greater than 1.0 mm within the first 2 years post-operation is considered unacceptable, with cups migrating between 0.2 and 1.0 mm at risk of having a revision rate exceeding 5% at 10 years.

An RSA study should be completed for any new implant under the principles of phased innovation in orthopaedics. This ensures the new device will achieve long-term, stable fixation prior to its widespread adoption. Many device manufacturers incorporate the results of the RSA migration study into their marketing material. The advantage of RSA is its high degree of accuracy and its well-established thresholds for implant migration, meaning a relatively small number of patients are required to provide meaningful results.

Several joint replacement companies (Microport excluded) have previously released new products to the marketplace without RSA evaluation and these implants have later been identified as having ingrowth problems. The scientific aim of this study is to prove efficacy of ingrowth with a recently released implant.

This study design will be a prospective cohort with a retrospective control group. The study will be conducted at a single centre (London Health Sciences Centre - University Hospital, London, Ontario, Canada) with all cases performed by a single, fellowship-trained high-volume surgeon.

The study group will receive a Prime cementless acetabular cup (manufactured by Microport located in Arlington, Tennessee). All patients will also receive a cementless Profemur femoral stem with a 32 mm Cobalt Chromium femoral head, articulating on a highly crosslinked acetabular liner. The control group will be a previously published cohort that received the Reflection cementless acetabular cup with Roughcoat coating (Smith & Nephew, Memphis, TN). This is a well-established cup with long-term survivorship available in multiple registries, making it an ideal comparator.

Demographic details will be recorded from each patient. Outcome scores will be collected pre-operatively and at each post-operative visit. Standard outcome scores at our centre are the Western and McMaster Universities Osteoarthritis Index (WOMAC), Short Form 12 (SF-12), and Harris Hip Score. At the time of surgery, n = 8 of 1.0 mm Tantalum beads will be inserted into the pelvis surrounding the acetabular cup. Patients will undergo post-operative supine RSA exams within 0-2 weeks (baseline exam) and at 6 weeks, 3 months, 6 months, 1 year, and 2 years, following standardized protocols. RSA exams will be conducted at Robarts with a member of the research team escorting participants over to Robarts for each required post-operative visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This study design will be a prospective cohort with a retrospective control group.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Fixation of the Prime Acetabular Cup
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Prime Cup
The study group will receive a Prime cementless acetabular cup (manufactured by Microport located in Arlington, Tennessee). All patients will also receive a cementless Profemur femoral stem with a 32 mm CoCr femoral head, articulating on a highly crosslinked acetabular liner.
Device: Prime Cup
Patients in this group will have the Prime cementless acetabular cup used during surgery.




Primary Outcome Measures :
  1. Implant Migration [ Time Frame: 2 years ]
    Migration will include translations, rotations and maximum total point motion measured between the 3D CAD models of the cup and the bone bead segment using model-based RSA software


Secondary Outcome Measures :
  1. Short Form 12 [ Time Frame: 2 years ]
    Patient-reported questionnaire to assess general health and quality of life. Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.

  2. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: 2 years ]
    Patient-reported questionnaire to assess function, stiffness and pain caused by hip or knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (function, stiffness and pain). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The total score is calculated by summing the scores for each subscale. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  3. Harris Hip Score [ Time Frame: 2 years ]
    The Harris Hip Scale (HHS) was developed for the assessment of the results of hip surgery, and is intended to evaluate various hip disabilities and methods of treatment in an adult population. It is a physician-completed instrument that consists of subscales for pain severity (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 0-4 points), and range of motion (2 items, 0-5 points). The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hip osteoarthritis
  • scheduled for primary total hip arthroplasty
  • ability to provide informed consent
  • over the age of 18 years

Exclusion Criteria:

  • prior arthroplasty on the indicated joint
  • individuals who do not speak or understand English
  • individuals with neuromuscular disorders or cognitive impairments
  • individuals ho live >100km from our centre and/or are unlikely to return for multiple follow-up appointments

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): NCT04039984


Contacts
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Contact: Matthew Teeter, PhD 519-685-8500 ext 34957 matthew.teeter@lhsc.on.ca
Contact: Lyndsay Somerville, PhD 519-685-8500 ext 36645 lyndsay.somerville@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
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Principal Investigator: Douglas Naudie, MD London Health Sciences Centre
Publications:
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Responsible Party: Douglas Naudie, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04039984    
Other Study ID Numbers: 113456
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Douglas Naudie, Lawson Health Research Institute:
radiostereometric analysis
implant migration
total hip replacement
arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases