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

NCT02518269 | Active Not Recruiting

• 1 other identifier: ORTHO.CR.GH33
• Study Type: interventional
• Target: 360
• Locations: 3 countries
• Sites: 5

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.

Conditions

Osteoarthrosis; Pain; Arthritis

Keywords

hip; arthroplasty; G7; EchoBimetric; E1; ceramic; Arcom XL

Outcome Measures

Primary Outcomes (1)

• Difference in osteolytic volume at 5 years postoperatively measured by CT scan.

  CT scan will be performed on 240 of the 360 patients post operatively and at 5 years follow up

  5 years

Secondary Outcomes (9)

• Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.

  3 months, 1,2,5,7 and 10 year follow up

• Implant positioning

  Immediately postoperative,1,2,5,7 and 10 year follow up

• Subjective satisfaction

  3 months, 1,2,5,7 and 10 year follow up

• Safety and survivorship

  Continously throughout the study until 10 years FU

• Squeaking evaluation

  3 months, 1,2,5,7,10 years

Study Arms (3)

G7 MoP (Arcom XL) + Echo BiMetric

ACTIVE COMPARATOR

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

G7 MoP (E1) + Echo BiMetric

ACTIVE COMPARATOR

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

G7 CoC + Echo BiMetric

ACTIVE COMPARATOR

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

Interventions

Hip Arthroplasty PROCEDURE

Hip Arthroplasty comparing 3 different bearings.

Also known as: 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

G7 CoC + Echo BiMetric; G7 MoP (Arcom XL) + Echo BiMetric; G7 MoP (E1) + Echo BiMetric

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Aalborg University Hospital

Aalborg, Denmark

Location

Hvidovre hospital

Copenhagen, Denmark

Location

Jokilaakson Terveys Oy

Jämsä, Finland

Location

Turku university hospital

Turku, Finland

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis; Pain; Arthritis

Interventions

Arthroplasty, Replacement, Hip; methyl N-acetylsibirosaminide; Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Organic Chemicals; Polysaccharides; Carbohydrates

Study Officials

• Anders Troelsen, MD, PhD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

• Henrik Malchau, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Ville Remes, MD, PhD

  Jokilaakson Terveys Oy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: August 7, 2015
• Study Start: May 4, 2015
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2); SE (1); DK (2)