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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain; Arthritis; Osteoarthrosis
• Intervention / Treatment: Procedure: Hip Arthroplasty

Detailed Description

DESIGN: Prospective 3 Arm Randomized controlled trial.

PURPOSE:To compare three commonly used contemporary bearings in Total Hip Arthroplasty (THA). In addition, to evaluate the safety and effectiveness of the G7 Cups and Echo BiMetric Stem in THA.

OUTCOME MEASURES: Osteolysis, clinical outcomes, patient satisfaction, intraoperative/surgical data, implant positioning, survivor ship, and adverse events.

POPULATION: 360 hips (240 will have CT scan for analysis of osteolysis).

ELIGIBILITY: Patients who meet inclusion and exclusion criteria defined in this protocol.

DURATION: All patients will be followed at 3 months, 1, 2, 5, 7 and 10 year postoperatively. Assuming the enrollment will be completed 18 months. The total study duration will be 11.5 years.

STUDY GROUPS/TREATMENTS

Group 1 - G7 Metal-on-Polyethylene (MoP) (Arcom XL) + Echo BiMetric Group 2 - G7 Metal-on-Polyethylene (MoP) (E1) + Echo BiMetric Group 3 - G7 Ceramic-on-Ceramic (CoC) + Echo BiMetric The study's primary efficacy endpoint will include the difference in osteolytic volume at 5 years postoperatively measured by Computertomografi (CT) scan.

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Aalborg University Hospital
  • Copenhagen, Denmark
    • Hvidovre Hospital
• Finland
  • Jämsä, Finland
    • Jokilaakson Terveys Oy
  • Turku, Finland
    • Turku University Hospital
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: G7 MoP (Arcom XL) + Echo BiMetric; 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; Hip Arthroplasty comparing 3 different bearings.; Other Names: 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
Active Comparator: G7 MoP (E1) + Echo BiMetric; 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; Hip Arthroplasty comparing 3 different bearings.; Other Names: 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
Active Comparator: G7 CoC + Echo BiMetric; 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; Hip Arthroplasty comparing 3 different bearings.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.	Oxford Hip score (OHS) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7 and 10 year follow up
Implant positioning	Implant positioning will be measured using Martell method .	Immediately postoperative,1,2,5,7 and 10 year follow up
Subjective satisfaction	Subjective satisfaction will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.	3 months, 1,2,5,7 and 10 year follow up
Safety and survivorship	Adverse Events will be reported including revisions at any post-operative time points	Continously throughout the study until 10 years FU
Squeaking evaluation	Evaluation of noise from the hip will be made at all follow up visits by a noise assessment form	3 months, 1,2,5,7,10 years
Pain Assessment	Pain will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.	3 months, 1,2,5,7,10 years
Health related quality of life	EQ5D (Health related quality of life questionnaire from Euro Qol) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years
Physical activity level	UCLA (University California Los Angeles activity questionnaire) will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years
Hip specific clinical patient outcome measure	Harris Hip score (HHS)will be collected from all the patients preoperative and at all follow up visits.	3 months, 1,2,5,7,10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Anders Troelsen, MD, PhD, Hvidovre University Hospital; Principal Investigator: Henrik Malchau, MD, PhD, Sahlgrenska University Hospital, Sweden; Principal Investigator: Ville Remes, MD, PhD, Jokilaakson Terveys Oy

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2015
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): November 30, 2030

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimated): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: arthroplasty; ceramic; hip; G7; EchoBimetric; E1; Arcom XL
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: ORTHO.CR.GH33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Plan is to publish articles for all the enrolled patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No