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A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty

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: NCT02518269
Recruitment Status : Active, not recruiting
First Posted : August 7, 2015
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:

The study is designed to compare three articulation options in terms of osteolysis, patient satisfaction, clinical and radiographic outcomes (Oxford Hip score (OHS) and Harris Hip score (HHS)) and safety.

In addition, the purpose of the study is also to evaluate the safety and effectiveness of patients who received G7 Acetabular system in conjunction with Echo BiMetric stem in primary total hip arthroplasty.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Pain Arthritis Procedure: Hip Arthroplasty Not Applicable

Detailed Description:

DESIGN: Prospective 3 Arm Randomized controlled trial.

PURPOSE:To compare three commonly used contemporary bearings in Total Hip Arthroplasty (THA). In addition, to evaluate the safety and effectiveness of the G7 Cups and Echo BiMetric Stem in THA.

OUTCOME MEASURES: Osteolysis, clinical outcomes, patient satisfaction, intraoperative/surgical data, implant positioning, survivor ship, and adverse events.

POPULATION: 360 hips (240 will have CT scan for analysis of osteolysis).

ELIGIBILITY: Patients who meet inclusion and exclusion criteria defined in this protocol.

DURATION: All patients will be followed at 3 months, 1, 2, 5, 7 and 10 year postoperatively. Assuming the enrollment will be completed 18 months. The total study duration will be 11.5 years.

STUDY GROUPS/TREATMENTS

Group 1 - G7 Metal-on-Polyethylene (MoP) (Arcom XL) + Echo BiMetric Group 2 - G7 Metal-on-Polyethylene (MoP) (E1) + Echo BiMetric Group 3 - G7 Ceramic-on-Ceramic (CoC) + Echo BiMetric The study's primary efficacy endpoint will include the difference in osteolytic volume at 5 years postoperatively measured by Computertomografi (CT) scan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
Actual Study Start Date : May 4, 2015
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: G7 MoP (Arcom XL) + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive an Arcom Xl liner and a metal head
Procedure: Hip Arthroplasty
Hip Arthroplasty comparing 3 different bearings.
Other Names:
  • G7 acetabular cup system,
  • Echo Bimetric Full profile stem
  • Neutral liner, Arcom XL
  • Neutral liner, E1
  • Ceramic liner
  • Monobloc Ceramic Biolox Delta Head, 32 mm
  • Cobolt chrome head, 32 mm
  • porous coated (PPS) titanium alloy shells

Active Comparator: G7 MoP (E1) + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and will be operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive an E1 liner and a metal head.
Procedure: Hip Arthroplasty
Hip Arthroplasty comparing 3 different bearings.
Other Names:
  • G7 acetabular cup system,
  • Echo Bimetric Full profile stem
  • Neutral liner, Arcom XL
  • Neutral liner, E1
  • Ceramic liner
  • Monobloc Ceramic Biolox Delta Head, 32 mm
  • Cobolt chrome head, 32 mm
  • porous coated (PPS) titanium alloy shells

Active Comparator: G7 CoC + Echo BiMetric
Eligible patients will be enrolled and planned for Hip Arthroplasty and operated with the Echo BiMetric femoral stem and G7 Acetabular cup. This group will receive a ceramic liner and a ceramic head
Procedure: Hip Arthroplasty
Hip Arthroplasty comparing 3 different bearings.
Other Names:
  • G7 acetabular cup system,
  • Echo Bimetric Full profile stem
  • Neutral liner, Arcom XL
  • Neutral liner, E1
  • Ceramic liner
  • Monobloc Ceramic Biolox Delta Head, 32 mm
  • Cobolt chrome head, 32 mm
  • porous coated (PPS) titanium alloy shells




Primary Outcome Measures :
  1. Difference in osteolytic volume at 5 years postoperatively measured by CT scan. [ Time Frame: 5 years ]
    CT scan will be performed on 240 of the 360 patients post operatively and at 5 years follow up


Secondary Outcome Measures :
  1. Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems. [ Time Frame: 3 months, 1,2,5,7 and 10 year follow up ]
    Oxford Hip score (OHS) will be collected from all the patients preoperative and at all follow up visits.

  2. Implant positioning [ Time Frame: Immediately postoperative,1,2,5,7 and 10 year follow up ]
    Implant positioning will be measured using Martell method .

  3. Subjective satisfaction [ Time Frame: 3 months, 1,2,5,7 and 10 year follow up ]
    Subjective satisfaction will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

  4. Safety and survivorship [ Time Frame: Continously throughout the study until 10 years FU ]
    Adverse Events will be reported including revisions at any post-operative time points

  5. Squeaking evaluation [ Time Frame: 3 months, 1,2,5,7,10 years ]
    Evaluation of noise from the hip will be made at all follow up visits by a noise assessment form

  6. Pain [ Time Frame: 3 months, 1,2,5,7,10 years ]
    Pain will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

  7. Health related quality of life [ Time Frame: 3 months, 1,2,5,7,10 years ]
    EQ5D (Health related quality of life questionnaire from Euro Qol) will be collected from all the patients preoperative and at all follow up visits.

  8. Physical activity level [ Time Frame: 3 months, 1,2,5,7,10 years ]
    UCLA (University California Los Angeles activity questionnaire) will be collected from all the patients preoperative and at all follow up visits.

  9. Hip specific clinical patient outcome measure [ Time Frame: 3 months, 1,2,5,7,10 years ]
    Harris Hip score (HHS)will be collected from all the patients preoperative and at all follow up visits.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient is 18 to 75 years of age, inclusive.

  • Patients determined to be suitable for uncemented fixation by investigator
  • Patient is skeletally mature.
  • Patient qualifies for primary unilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:

    • Osteoarthritis (OA)
    • Developmental Dysplasia without subluxation
  • Patient is willing and able to provide written informed consent.
  • Patient is willing and able to cooperate in the required post-operative therapy.
  • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.

Exclusion Criteria:

The patient is:

  • A prisoner
  • Mentally incompetent or unable to understand what participation in the study entails
  • A known alcohol or drug abuser
  • Anticipated to be non-compliant.

    • The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
    • The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
    • The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
    • The patient is known to be pregnant.
    • The patient is unwilling or unable to give informed consent, or to comply with the follow-up program.
    • The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously.

The patient has had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.

  • The patient has insufficient bone stock to fix the component. Insufficient bone stock exists (ex: Dorr type C) in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation.
  • Estimated cup size smaller than 48 or stem size smaller than 7
  • The patient has known local bone tumors in the operative hip.

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): NCT02518269


Locations
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Denmark
Aalborg University Hospital
Aalborg, Denmark
Hvidovre hospital
Copenhagen, Denmark
Finland
Jokilaakson Terveys Oy
Jämsä, Finland
Turku university hospital
Turku, Finland
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Anders Troelsen, MD, PhD Hvidovre University Hospital
Principal Investigator: Henrik Malchau, MD, PhD Sahlgrenska University Hospital, Sweden
Principal Investigator: Ville Remes, MD, PhD Jokilaakson Terveys Oy
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02518269    
Other Study ID Numbers: ORTHO.CR.GH33
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Plan is to publish articles for all the enrolled patients.

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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 Zimmer Biomet:
hip
arthroplasty
G7
EchoBimetric
E1
ceramic
Arcom XL
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases