G7 Dual Mobility With Vivacit-E or Longevity PMCF (NCT05548972) | Clinical Trial Compass
By InvitationNot Applicable
G7 Dual Mobility With Vivacit-E or Longevity PMCF
United States358 participantsStarted 2023-03-20
Plain-language summary
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patient is 18 to 80 years of age, inclusive
* Patient is skeletally mature
* Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:
* Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Dislocation risks
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
* Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent
Exclusion Criteria:
* Patient is septic, has an active infection or has osteomyelitis at the affected joint
* Patient has significant osteoporosis as defined by treating surgeon
* Patient has metabolic disorder(s) which may impair bone formation
* Patient has osteomalacia
* Patient has distant foci of infections which may spread to the implant site
* Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs
* Patient underwent contralateral THA within 3 months of planned index procedure or…