OsteoarthrosisNCT02518269
A 3-Arm Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
A study testing Hip Arthroplasty in people with Osteoarthrosis and Pain, run by Zimmer Biomet at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthrosis, Pain, Arthritis
- What is being tested?
- Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 4 May 2015to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark2 sites
Aalborg University Hospital
Aalborg
Hvidovre hospital
Copenhagen
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthrosis, Pain, Arthritis
- Being tested
- Hip Arthroplasty
- Keywords
- hip, arthroplasty, G7, EchoBimetric, E1, ceramic, Arcom XL
- Medical subject headings
- Osteoarthritis, Pain, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip ArthroplastyProcedure or surgery
Also called G7 acetabular cup system,, Echo Bimetric Full profile stem, Neutral liner, Arcom XL, Neutral liner, E1
Hip Arthroplasty comparing 3 different bearings.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Procedure: Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (9)
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.
Measured: 3 months, 1,2,5,7 and 10 year follow up
Implant positioning
Implant positioning will be measured using Martell method .
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months, 1,2,5,7,10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start4 May 2015
- Primary completionJun 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthrosisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Troelsen, MD, PhD, Principal investigator, Hvidovre University HospitalHenrik Malchau, MD, PhD, Principal investigator, Sahlgrenska University HospitalVille Remes, MD, PhD, Principal investigator, Jokilaakson Terveys Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02518269
- Sponsor's protocol ID
- ORTHO.CR.GH33
- Status last verified
- Nov 2025
- First submitted
- 29 Apr 2015
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan is to publish articles for all the enrolled patients.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective 3-Arm Randomized Controlled Study on G7 Acetabular Cup With Echo BiMetric Stem in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02518269
- Acronym / sponsor ID
- ORTHO.CR.GH33
- Conditions
- Osteoarthrosis, Pain, Arthritis
- Keywords
- hip, arthroplasty, G7, EchoBimetric, E1, ceramic, Arcom XL
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 4 May 2015 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| G7 MoP (Arcom XL) + Echo BiMetric | Active comparator | Procedure: Hip ArthroplastyEligible 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 |
| G7 MoP (E1) + Echo BiMetric | Active comparator | Procedure: Hip ArthroplastyEligible 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. |
| G7 CoC + Echo BiMetric | Active comparator | Procedure: Hip ArthroplastyEligible 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Patient is willing and able to provide written informed consent.
Key exclusion criteria (15 listed)
- 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 had previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip ArthroplastyAlso: G7 acetabular cup system,, Echo Bimetric Full profile stem, Neutral liner, Arcom XL, Neutral liner, E1Hip Arthroplasty comparing 3 different bearings. | Procedure or surgery | G7 CoC + Echo BiMetric, G7 MoP (Arcom XL) + Echo BiMetric, G7 MoP (E1) + Echo BiMetric |
Primary outcome
Difference in osteolytic volume at 5 years postoperatively measured by CT scan.
Time frame: 5 years
CT scan will be performed on 240 of the 360 patients post operatively and at 5 years follow up
9 secondary outcomes
Hip specific clinical outcome in patients who received the one of the above mentioned combinations of total hip systems.
Time frame: 3 months, 1,2,5,7 and 10 year follow up
Implant positioning
Time frame: Immediately postoperative,1,2,5,7 and 10 year follow up
Subjective satisfaction
Time frame: 3 months, 1,2,5,7 and 10 year follow up
Safety and survivorship
Time frame: Continously throughout the study until 10 years FU
Squeaking evaluation
Time frame: 3 months, 1,2,5,7,10 years
Pain Assessment
Time frame: 3 months, 1,2,5,7,10 years
Health related quality of life
Time frame: 3 months, 1,2,5,7,10 years
Physical activity level
Time frame: 3 months, 1,2,5,7,10 years
Hip specific clinical patient outcome measure
Time frame: 3 months, 1,2,5,7,10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No. Plan is to publish articles for all the enrolled patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Troelsen, MD, PhD principal investigator
Hvidovre University Hospital
Henrik Malchau, MD, PhD principal investigator
Sahlgrenska University Hospital
Ville Remes, MD, PhD principal investigator
Jokilaakson Terveys Oy
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip Arthroplasty in people with Osteoarthrosis and Pain, run by Zimmer Biomet at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in osteolytic volume at 5 years postoperatively measured by CT scan. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.