Survival of the Implants With Revision as EndpointNCT01118247
Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation
A study testing Uncemented primary total hip arthroplasty in people with Survival of the Implants With Revision as Endpoint and Clinical Performance With HHS, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Survival of the Implants With Revision as Endpoint, Clinical Performance With HHS, Patients Satisfaction With the Hip Implant
- What is being tested?
- Uncemented primary total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2004to Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or secondary osteoarthrosis.
- Both gender, less than seventy years.
- Patients operated for FCF and patients with previous osteotomies are included.
Who cannot join
- Treatment with Prednisolon.
- Osteomyelitis.
- Serious infections illnesses.
- Cancer or metastasis.
- Rheumatoid arthritis.
- Osteonecrosis after use of alcohol or medicaments.
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- Kidney illnesses.
- Metabolic bone diseases.
- Earlier hip arthrodesis.
- Allergic reactions on implants.
- Patients who do not cooperate on rehabilitation.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Ortopaedic Department, University Hospital of North Norway
Tromsø, 9016
About this study
Official title: Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.
The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.
Read more
Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.
0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.
Read the detailed description
Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories).
Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem.
Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design.
At present 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.
548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 years.
- Conditions
- Survival of the Implants With Revision as Endpoint, Clinical Performance With HHS, Patients Satisfaction With the Hip Implant
- Being tested
- Uncemented primary total hip arthroplasty
- Keywords
- Uncemented THA, alumina-on-alumina, survival, HHS, Patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented primary total hip arthroplastyProcedure or surgery
Also called Cup: Igloo, Biotechni, Fr, Stem: Filler, Biotechni, Fr, Head, liner: Biotechni, Fr, Morgan, GB
Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
| Study group | Role | What they receive |
|---|---|---|
| pure Ti | Experimental | Cup and stem partly coated with pure titanium Receives: Procedure: Uncemented primary total hip arthroplasty |
| pure Ti and HA | Active comparator | Cup and stem partly coated with pure titanium, and fully coated with HA. Receives: Procedure: Uncemented primary total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival with revision as endpoint.
Measured: 5-20 years
Secondary outcomes (3)
Clinical outcome with Harris Hip Score.
Measured: 10-30 years
Radiographic outcome.
The radiographic evaluation will be carried out postoperatively, 2, 5, 10, 15 and 20 years after the operations with the same protocol modified after Johnston et al, JBJS Am. 1990;72: page 166. We judge and compare a.p pelvic x-rays calibrated on the computer.
Measured: 10-30years
Patient satisfaction with the hip prosthesis.
At the consultations we ask the patient if he/she is satisfied with the hip. The patient may answer i 5 categories (dissatisfied, not satisfied, satisfied, very satisfied and very much satisfied). We also have registrations on early and late complications, leg length discrepancy, Trendelenburg lurch etc.
Measured: 10-30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startApr 2004
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival of the Implants With Revision as EndpointStudies 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
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olav Reikerås, MD, Prof, Study director, Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.Arvid Småbrekke, MD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118247
- Sponsor's protocol ID
- P-REK NORD 44/206
- Other IDs
- 200602701-8/IAY/400
- Status last verified
- Feb 2019
- First submitted
- 30 Apr 2010
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Uncemented Total Hip Prosthesis With Pure Ti With and Without HA, and Alumina-on-alumina Articulation
- ClinicalTrials.gov ID
- NCT01118247
- Acronym / sponsor ID
- P-REK NORD 44/206
- Conditions
- Survival of the Implants With Revision as Endpoint, Clinical Performance With HHS, Patients Satisfaction With the Hip Implant
- Keywords
- Uncemented THA, alumina-on-alumina, survival, HHS, Patient satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 6 May 2010 (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.
Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.
The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.
Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.
0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.
Detailed description
Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories).
Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem.
Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design.
At present 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.
548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pure Ti | Experimental | Procedure: Uncemented primary total hip arthroplastyCup and stem partly coated with pure titanium |
| pure Ti and HA | Active comparator | Procedure: Uncemented primary total hip arthroplastyCup and stem partly coated with pure titanium, and fully coated with HA. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or secondary osteoarthrosis.
- Both gender, less than seventy years.
- Patients operated for FCF and patients with previous osteotomies are included.
Key exclusion criteria (11 listed)
- Treatment with Prednisolon.
- Osteomyelitis.
- Serious infections illnesses.
- Cancer or metastasis.
- Rheumatoid arthritis.
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 |
|---|---|---|
| Uncemented primary total hip arthroplastyAlso: Cup: Igloo, Biotechni, Fr, Stem: Filler, Biotechni, Fr, Head, liner: Biotechni, Fr, Morgan, GBTotal hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT. | Procedure or surgery | pure Ti, pure Ti and HA |
Primary outcome
Survival with revision as endpoint.
Time frame: 5-20 years
3 secondary outcomes
Clinical outcome with Harris Hip Score.
Time frame: 10-30 years
Radiographic outcome.
Time frame: 10-30years
Patient satisfaction with the hip prosthesis.
Time frame: 10-30 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
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.
Olav Reikerås, MD, Prof study director
Department of Orthopaedics, Rikshospitalet University Clinic, University of Oslo, N-0027 Oslo, Norway.
Arvid Småbrekke, MD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented primary total hip arthroplasty in people with Survival of the Implants With Revision as Endpoint and Clinical Performance With HHS, run by University Hospital of North Norway at 1 site in Norway.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Feb 2019. 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 Norway. 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?
Results are not available in the source record.
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?
Survival with revision as endpoint. (time frame: 5-20 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 19 Feb 2019.