OsteoarthritisNCT02316704
Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty
A study testing THA with G7 PPS coted acetabular component and THA with G7 OsseoTi coted acetabular component in people with Osteoarthritis, run by Hvidovre University Hospital at 2 sites in 2 countries.
Trial summary
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- THA with G7 PPS coted acetabular component and THA with G7 OsseoTi coted acetabular component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2014to Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
- Participants must be 18-75 years of age.
- Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
- Participants must be able to give informed consent and be cognitively intact.
- Participants must be expected to be able to complete all postoperative controls.
- Participants must not have severe comorbidities, ASA-score ≤ 3.
Who cannot join
- Terminal illness.
- Rheumatoid arthritis.
- Previous fracture of the hip.
- Osteonecrosis of the hip.
- Previous infection of the hip.
- Severe bony deformity warranting the use of non-standard implants.
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- Metastasis in the periarticular bone or proximal femur.
- Female patients that are pregnant or planning pregnancy during follow-up period
- If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
- Documented osteoporosis with patient in active medical treatment.
- Comorbidity with altered pain perception (e.g. DM with neuropathy).
- Participants that develop deep infection in the follow-up period are excluded from the project.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Denmark1 site
Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, 2650
Sweden1 site
Sahlgrenska University Hospital, Department of Orthopedics,
Gothenburg, SW-431 80
About this study
Official title: Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
- Conditions
- Osteoarthritis
- Being tested
- THA with G7 PPS coted acetabular component, THA with G7 OsseoTi coted acetabular component
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA with G7 PPS coted acetabular componentDevice
THA with G7 OsseoTi coted acetabular componentDevice
| Study group | Role | What they receive |
|---|---|---|
| OsseoTi™ G7 large | Active comparator | OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm) Receives: Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component |
| OsseoTi™ G7 32 | Active comparator | OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head Receives: Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component |
| conventional PPS coated G7 large | Active comparator | conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm) Receives: Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component |
| conventional PPS coated G7 32 | Active comparator | conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head Receives: Device: THA with G7 PPS coted acetabular component; Device: THA with G7 OsseoTi coted acetabular component |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Gromov, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316704
- Sponsor's protocol ID
- G7_RSA_v1.02
- Status last verified
- Feb 2021
- First submitted
- 6 Dec 2014
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsikandylakis G, Mortensen KRL, Gromov K, Mohaddes M, Malchau H, Troelsen A. The Use of Large Metal Heads in Thin Vitamin E-Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial. J Arthroplasty. 2024 Jul;39(7):1804-1810. doi: 10.1016/j.arth.2024.02.008. Epub 2024 Feb 11.
PubMed 38350518
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixation of OsseoTi™ Porous Structure Versus PPS (Porous Plasma Spray) Coating on the G7™ Acetabular Component for Primary Total Hip Arthroplasty: A Single-Blinded Randomized Controlled Trial Evaluating Implant Migration, Acetabular Liner Wear, and Patient Reported Outcome
- ClinicalTrials.gov ID
- NCT02316704
- Acronym / sponsor ID
- G7_RSA_v1.02
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 15 Dec 2014 (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 primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OsseoTi™ G7 large | Active comparator | Device: THA with G7 PPS coted acetabular component, Device: THA with G7 OsseoTi coted acetabular componentOsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm) |
| OsseoTi™ G7 32 | Active comparator | Device: THA with G7 PPS coted acetabular component, Device: THA with G7 OsseoTi coted acetabular componentOsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head |
| conventional PPS coated G7 large | Active comparator | Device: THA with G7 PPS coted acetabular component, Device: THA with G7 OsseoTi coted acetabular componentconventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm) |
| conventional PPS coated G7 32 | Active comparator | Device: THA with G7 PPS coted acetabular component, Device: THA with G7 OsseoTi coted acetabular componentconventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
Key exclusion criteria (12 listed)
- Terminal illness.
- Rheumatoid arthritis.
- Previous fracture of the hip.
- Osteonecrosis of the hip.
- Previous infection of the hip.
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 |
|---|---|---|
| THA with G7 PPS coted acetabular component | Device | OsseoTi™ G7 32, OsseoTi™ G7 large, conventional PPS coated G7 32, conventional PPS coated G7 large |
| THA with G7 OsseoTi coted acetabular component | Device | OsseoTi™ G7 32, OsseoTi™ G7 large, conventional PPS coated G7 32, conventional PPS coated G7 large |
Primary outcome
RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.
Time frame: 2 year
Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.
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 9 Feb 2021.
- Derived from this study: PubMed 38350518Tsikandylakis G, Mortensen KRL, Gromov K, Mohaddes M, Malchau H, Troelsen A. The Use of Large Metal Heads in Thin Vitamin E-Doped Cross-Linked Polyethylene Inserts Does Not Increase Polyethylene Wear in Total Hip Arthroplasty: 5-Year Results From a Randomized Controlled Trial. J Arthroplasty. 2024 Jul;39(7):1804-1810. doi: 10.1016/j.arth.2024.02.008. Epub 2024 Feb 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THA with G7 PPS coted acetabular component and THA with G7 OsseoTi coted acetabular component in people with Osteoarthritis, run by Hvidovre University Hospital at 2 sites in 2 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 6 inclusion and 12 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, 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?
RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA. (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316704, which also lists 1 linked publication.
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 9 Feb 2021.