G7 BiSpherical Acetabular Shell PMCF Study

NCT03266874 | Active Not Recruiting

• 1 other identifier: H.CR.I.EU.16.26
• Study Type: observational
• Target: 160
• Locations: 4 countries
• Sites: 5

Brief Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.

Conditions

Rheumatoid Arthritis; Osteoarthritis; Noninflammatory Degenerative Joint Disease; Avascular Necrosis; Correction of Functional Deformity; Non-Union Fracture; Femoral Neck Fractures; Trochanteric Fractures

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• Implant survivorship is assessed counting the number of implant revisions

  10 years

Secondary Outcomes (3)

• Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire

  10 years

• Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire

  10 years

• Safety is assessed according to the number of complications which are collected via adverse event forms.

  10 years

Study Arms (1)

Patients who received the G7 BiSpherical Cup

Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in need of a Total Hip Arthroplasty (primary or revision) which receive the G7 BiSperical Acetabular Shell and who meet all of the inclusion and none of the exclusion criteria.

You may qualify if:

• Patient capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
• Patient aged of 18 years or more whose skeleton reached bone maturity.
• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• 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.
• The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to con-strained acetabular components have been considered.

You may not qualify if:

• Infection, sepsis, osteomyelitis.
• Uncooperative patient or patient with neurologic disorders who is incapable of following directions.
• Osteoporosis.
• Metabolic disorders which may impair bone formation.
• Osteomalacia.
• Distant foci of infections which may spread to the implant site.
• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
• Vascular insufficiency, muscular atrophy or neuromuscular disease.
• Patient unwilling or unable to give consent, or to comply with the follow-up program.
• Patient known to be pregnant or breastfeeding.
• Patient presenting any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.
• Patient institutionalized or known drug abuser or alcoholic or anyone who cannot understand what is required of them.
• Patient belonging to a vulnerable population.
• Bone or musculature compromised by disease, infection, or prior implantation that cannot provide adequate support or fixation for the prosthesis.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Cabinet du Dr. Miazzolo

Perpignan, 66000, France

Location

Orthopädische Chirurgie Müchen OCM

Munich, Bavaria, 81369, Germany

Location

Herzogin Elisabeth Hospital

Braunschweig, Lower Saxony, 38124, Germany

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Orthoprax AG

Bern, 3012, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Osteonecrosis; Fractures, Ununited; Femoral Neck Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 30, 2017
• Study Start: December 10, 2017
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

DE (2); CH (1); FR (1); NL (1)