Clinical trial NCT04031209: G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
Official title: Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Fractures
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 275
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.

Brief summary: This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.

Detailed description: The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting

Eligibility criteria: Inclusion Criteria:

* 55 to 80 years of age, inclusive
* Skeletally mature
* Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
* Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent

Exclusion Criteria:

* Is septic, has an active infection or has osteomyelitis at the affected joint
* Has significant osteoporosis as defined by treating surgeon
* Has metabolic disorder(s) which may impair bone formation
* Has osteomalacia
* Has distant foci of infections which may spread to the implant site
* Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
* Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
* Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
* Is known to be pregnant
* Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
* Has a known sensitively or allergy to one or more of

Primary outcomes:
measure: Implant dislocation rate
timeFrame: One year post-surgery
Secondary outcomes:
measure: Pain and Functional Performance by Oxford Hip Score
timeFrame: Up to 5 years post-surgery
measure: Implant survivorship by revision rates
timeFrame: Up to 5 years post-surgery
measure: Quality of life by EQ-5D-5L questionnaire
timeFrame: Up to 5 years post-surgery
measure: Quality of life by JHEQ
timeFrame: Up to 5 years post-surgery
measure: Pain and Functional Performance by JOA Hip Score
timeFrame: Up to 5 years post-surgery
measure: Adverse events reported
timeFrame: Up to 5 years post-surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan medical Centre
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
Study officials:
affiliation: Kyunghee University Medical Center
name: Kee-Hyung Rhyu
role: PRINCIPAL_INVESTIGATOR
References: