Hip ArthrosisNCT01420900
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design
A study testing THA with ABG II / Trident and THA with CLS / Trilogy in people with Hip Arthrosis, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Hip Arthrosis
- What is being tested?
- THA with ABG II / Trident and THA with CLS / Trilogy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2011to 3 Nov 2017
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients scheduled for uncemented THA under the age of 65 years.
Who cannot join
- Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
- Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
- Severely impaired level of function due to other physical deficiencies than the hip.
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Earlier primary THA or revision THA in the contralateral hip.
- Pathology requiring another prosthesis concept than the below mentioned.
- Body mass index greater than 35.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design
The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.
- Conditions
- Hip Arthrosis
- Being tested
- THA with ABG II / Trident, THA with CLS / Trilogy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THA with ABG II / TridentDevice
Surgery with total hip arthroplasty in the form of ABG II / Trident
THA with CLS / TrilogyDevice
Surgery with total hip arthroplasty in the form of CLS / Trilogy
| Study group | Role | What they receive |
|---|---|---|
| ABG II / Trident | Active comparator | Not described Receives: Device: THA with ABG II / Trident |
| CLS / Trilogy | Active comparator | Not described Receives: Device: THA with CLS / Trilogy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All noises from THA
Measured: One year
Secondary outcomes (1)
Life quality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthrosisStudies 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Varnum, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420900
- Sponsor's protocol ID
- man2if
- Status last verified
- Nov 2017
- First submitted
- 19 Aug 2011
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design
- ClinicalTrials.gov ID
- NCT01420900
- Acronym / sponsor ID
- man2if
- Conditions
- Hip Arthrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 22 Aug 2011 (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 investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABG II / Trident | Active comparator | Device: THA with ABG II / Trident |
| CLS / Trilogy | Active comparator | Device: THA with CLS / Trilogy |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients scheduled for uncemented THA under the age of 65 years.
Key exclusion criteria (7 listed)
- Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
- Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
- Severely impaired level of function due to other physical deficiencies than the hip.
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Earlier primary THA or revision THA in the contralateral 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 ABG II / TridentSurgery with total hip arthroplasty in the form of ABG II / Trident | Device | ABG II / Trident |
| THA with CLS / TrilogySurgery with total hip arthroplasty in the form of CLS / Trilogy | Device | CLS / Trilogy |
Primary outcome
All noises from THA
Time frame: One year
1 secondary outcome
Life quality
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THA with ABG II / Trident and THA with CLS / Trilogy in people with Hip Arthrosis, run by Vejle Hospital 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 7 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All noises from THA (time frame: One year). 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 7 Nov 2017.