Osteoarthritis, HipNCT03279276
Selecting the Right Hip Prosthesis for Young Patients
A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to Dec 2029
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.
- Patients who wish to participate in the project and give written consent after oral and written information.
Who cannot join
- Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
- Smoking more than 20 cigarettes daily
- Patients with fracture in the femur or acetabulum.
- Patients who do not understand the given patient information
- Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
- Estimated residual life <10 years
Show all 18Show fewer
- Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
- Previous surgery on the relevant hip joint.
- Co-Morbidity (ASA Group 3-5).
- Neurological disorder that compromises motor skills and rehabilitation.
- Pregnancy.
- Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
- Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
- Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
- Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
- Aseptic caput necrosis (posttraumatic, idiopathic).
- Varus or valgus deformity in proximal femur (collum angle <125 ° or> 145 °.)
- Collum femoris assessed too retro- or anteverted.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Clinic Farsø, Aalborg University Hospital
Farsø, Northern Jutland
About this study
Official title: Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.
There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.
Read the detailed description
The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.
The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.
The secondary outcomes are to assess:
- The hip function measured by gait analysis.
- Hip strength at pressure gauge.
- Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
- Patient satisfaction measured by PROMs.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- Hip arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.
By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector.
| Study group | Role | What they receive |
|---|---|---|
| Primoris | Experimental | Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®. Receives: Procedure: Total Hip Arthroplasty |
| Echo | Active comparator | Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®. Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
Measured: 2 -10 years
Secondary outcomes (8)
Gait analysis
Walking function measured by gait analysis and hip strength at dynamometer test pre and 12 months postoperatively.
Measured: 1 year
Radio Stereometric Analysis (RSA)
Prosthetic migration / migration measured by X-ray Radio-stereophotogrametic-analyzes
Measured: 2-10 years
European Quality of life in 5 Dimensions (EQ5D)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
Harris Hip Score (HHS)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
Oxford Hip Score (OHS),
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
University of California Los Angeles Activity Score (UCLA)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
Forgotten Joint Score (FJS)
This is a well defined Patient Reported Outcome Measure (PROM) that doesn't need further explanation.
Measured: 2-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jun 2018
- Primary completion10 Dec 2019
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mogens Laursen, MD, PhD, Principal investigator, Northern ODD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279276
- Sponsor's protocol ID
- N-20170030
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.
- ClinicalTrials.gov ID
- NCT03279276
- Acronym / sponsor ID
- N-20170030
- Conditions
- Osteoarthritis, Hip
- Keywords
- Hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- Dec 2029 (estimated)
- First posted
- 12 Sep 2017 (actual)
- 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.
There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.
Detailed description
The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.
The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.
The secondary outcomes are to assess:
- The hip function measured by gait analysis.
- Hip strength at pressure gauge.
- Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
- Patient satisfaction measured by PROMs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Primoris | Experimental | Procedure: Total Hip ArthroplastyTotal hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®. |
| Echo | Active comparator | Procedure: Total Hip ArthroplastyTotal hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.
- Patients who wish to participate in the project and give written consent after oral and written information.
Key exclusion criteria (18 listed)
- Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
- Smoking more than 20 cigarettes daily
- Patients with fracture in the femur or acetabulum.
- Patients who do not understand the given patient information
- Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
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 |
|---|---|---|
| Total Hip ArthroplastyThe usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load. By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector. | Procedure or surgery | Echo, Primoris |
Primary outcome
Bone Mineral Density
Time frame: 2 -10 years
Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
8 secondary outcomes
Gait analysis
Time frame: 1 year
Radio Stereometric Analysis (RSA)
Time frame: 2-10 years
European Quality of life in 5 Dimensions (EQ5D)
Time frame: 2-10 years
Harris Hip Score (HHS)
Time frame: 2-10 years
Oxford Hip Score (OHS),
Time frame: 2-10 years
University of California Los Angeles Activity Score (UCLA)
Time frame: 2-10 years
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2-10 years
Forgotten Joint Score (FJS)
Time frame: 2-10 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 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Mogens Laursen, MD, PhD principal investigator
Northern ODD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
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 2 inclusion and 18 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Bone Mineral Density (time frame: 2 -10 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 8 Apr 2022.