G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture

NCT04031209 | Active Not Recruiting FDA Device

• 1 other identifier: CSA2019-02H
• Study Type: observational
• Target: 275
• Locations: 1 country
• Sites: 7

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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Implant dislocation rate

  Dislocation is defined as the complete loss of articulation contact between two artificial joint components.

  One year post-surgery

Secondary Outcomes (6)

• Pain and Functional Performance by Oxford Hip Score

  Up to 5 years post-surgery

• Implant survivorship by revision rates

  Up to 5 years post-surgery

• Quality of life by EQ-5D-5L questionnaire

  Up to 5 years post-surgery

• Quality of life by JHEQ

  Up to 5 years post-surgery

• Pain and Functional Performance by JOA Hip Score

  Up to 5 years post-surgery

Study Arms (1)

G7 G7 Acetabular System

All patients will receive G7 G7 Acetabular System

Device: G7 Acetabular System

Interventions

G7 Acetabular System DEVICE

All patients will receive G7 Acetabular System

G7 G7 Acetabular System

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (7)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hanyang University Medical Center

Seoul, 04763, South Korea

Location

Asan medical Centre

Seoul, 05505, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

KyungHee University Medical Center

Seoul, 130-872, South Korea

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Kee-Hyung Rhyu

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2019
• First Posted: July 24, 2019
• Study Start: January 1, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)