Back to results

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

Primary Purpose

Osteoarthrosis, Pain, Arthritis

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Hip Arthroplasty

About this trial

This is an interventional treatment trial for Osteoarthrosis focused on measuring hip, arthroplasty, G7, EchoBimetric, E1, ceramic, Arcom XL

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Aalborg University Hospital
Hvidovre hospital
Jokilaakson Terveys Oy
Turku university hospital
Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

G7 MoP (Arcom XL) + Echo BiMetric

G7 MoP (E1) + Echo BiMetric

G7 CoC + Echo BiMetric

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Implant positioning

Implant positioning will be measured using Martell method .

Subjective satisfaction

Subjective satisfaction will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

Safety and survivorship

Adverse Events will be reported including revisions at any post-operative time points

Squeaking evaluation

Evaluation of noise from the hip will be made at all follow up visits by a noise assessment form

Pain Assessment

Pain will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

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.

Physical activity level

UCLA (University California Los Angeles activity questionnaire) will be collected from all the patients preoperative and at all follow up visits.

Hip specific clinical patient outcome measure

Harris Hip score (HHS)will be collected from all the patients preoperative and at all follow up visits.

Full Information

NCT ID

NCT02518269

First Posted

April 29, 2015

Last Updated

February 16, 2023

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT02518269

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 4, 2015 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

November 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthrosis, Pain, Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G7 MoP (Arcom XL) + Echo BiMetric

Arm Type

Active Comparator

Arm Description

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

Arm Title

G7 MoP (E1) + Echo BiMetric

Arm Type

Active Comparator

Arm Description

Arm Title

G7 CoC + Echo BiMetric

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Hip Arthroplasty

Other Intervention Name(s)

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

Intervention Description

Hip Arthroplasty comparing 3 different bearings.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

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

Description

Oxford Hip score (OHS) will be collected from all the patients preoperative and at all follow up visits.

Time Frame

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

Title

Implant positioning

Description

Implant positioning will be measured using Martell method .

Time Frame

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

Title

Subjective satisfaction

Description

Subjective satisfaction will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

Time Frame

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

Title

Safety and survivorship

Description

Adverse Events will be reported including revisions at any post-operative time points

Time Frame

Continously throughout the study until 10 years FU

Title

Squeaking evaluation

Description

Evaluation of noise from the hip will be made at all follow up visits by a noise assessment form

Time Frame

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

Title

Pain Assessment

Description

Pain will be collected using Numerical Rating Scale (NRS) and will be collected preoperative and at all follow ups.

Time Frame

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

Title

Health related quality of life

Description

EQ5D (Health related quality of life questionnaire from Euro Qol) will be collected from all the patients preoperative and at all follow up visits.

Time Frame

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

Title

Physical activity level

Description

UCLA (University California Los Angeles activity questionnaire) will be collected from all the patients preoperative and at all follow up visits.

Time Frame

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

Title

Hip specific clinical patient outcome measure

Description

Harris Hip score (HHS)will be collected from all the patients preoperative and at all follow up visits.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Troelsen, MD, PhD

Organizational Affiliation

Hvidovre University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henrik Malchau, MD, PhD

Organizational Affiliation

Sahlgrenska University Hospital, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ville Remes, MD, PhD

Organizational Affiliation

Jokilaakson Terveys Oy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aalborg University Hospital

City

Aalborg

Country

Denmark

Facility Name

Hvidovre hospital

City

Copenhagen

Country

Denmark

Facility Name

Jokilaakson Terveys Oy

City

Jämsä

Country

Finland

Facility Name

Turku university hospital

City

Turku

Country

Finland

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Plan is to publish articles for all the enrolled patients.

Learn more about this trial

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

We'll reach out to this number within 24 hrs