Hip ArthritisNCT01289834
A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
A study testing Hi-Fatigue Bone Cement and Palacos Bone Cement in people with Hip Arthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses). Read more about this study
- Who is it for?
- Ages 71 years and older
- Conditions the study is for
- Hip Arthritis
- What is being tested?
- Hi-Fatigue Bone Cement and Palacos Bone Cement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2010to Jan 2024
- 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 71 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- primary hip osteoarthritis
- sufficient bone quality for total hip arthroplasty
- age 71 years and above
- no upper age limit if the patient is capable
- informed and written consent
- patient can only enter the project with one hip
Who cannot join
- planned bilateral hip surgery
- neuromuscular or vascular disease in the affected leg
- preoperatively not found suitable for a hip arthroplasty
- patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
- fracture sequelae, osteonecrosis or previous extensive hip surgery
- patients who cannot refrain from taking NSAID post-operatively
Show all 23Show fewer
- continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
- patients with metabolic bone disease
- patients with rheumatoid arthritis
- postmenopausal women in systemic estrogenic hormone substitution
- patients with a continuous need of systemic cortisone treatment
- non-Danish citizenship
- patients who do not comprehend the Danish language (read and speak)
- senile dementia
- alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
- drug abuse
- major psychiatric disease
- metastatic cancer disease and treatment with radiation therapy or chemotherapy
- severe systemic disease (e.g. hemi paresis and Parkinson disease)
- systemic hip and spine disease
- employee at the orthopaedic department, Aarhus University Hospital
- ongoing case regarding industrial injury insurance of the knee
- patients with poor dental status (risk of infection)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Kjeld Soballe, Orthopaedic center, University of Aarhus
Aarhus, 8000
About this study
Official title: A Migration (RSA) and Bone Density (DEXA) Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement in Fixation of a Smooth vs. a Fine-blasted Femoral Stem. A Prospective Randomized Study on Primary Total Hip Arthroplasty.
The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).
Read the detailed description
A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.
- 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
- 25 CPT femoral stems fixed with Palacos Bone Cement.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
- Conditions
- Hip Arthritis
- Being tested
- Hi-Fatigue Bone Cement, Palacos Bone Cement
- Keywords
- RSA, Bone Cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hi-Fatigue Bone CementDevice
Hi-Fatigue bone cement is a new development of Aap Biomaterials, GmbH \& Co that has not yet been tested in the clinical setting. Hi-Fatigue has a medium to low viscosity. Laboratory tests confirm Hi-Fatigue bone cement to have properties equivalent to or better than the golden standard bone cement" Palacos. Hi-Fatigue is to be used without pre-chilling. When mixed at a room temperature of 21°C Hi-Fatigue has a low initial viscosity improving mixing and theoretically reducing the porosity of the cured cement.
Palacos Bone CementDevice
Palacos Bone Cement has been used for 48 years and has a good reputation as the "gold standard" among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing
| Study group | Role | What they receive |
|---|---|---|
| Hi-Fatigue Bone Cement | Active comparator | CPT femoral stems fixed with Hi-Fatigue Bone Cement Receives: Device: Hi-Fatigue Bone Cement |
| Palacos Bone Cement | Active comparator | CPT femoral stems fixed with Palacos Bone Cement Receives: Device: Palacos Bone Cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral component migration (roentgen stereo photogrammetric analysis - RSA)
Migration of the femoral component is measured over time and in respect to the femur bone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionApr 2016
- Study completionJan 2024
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 Hip ArthritisStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, Professor MD, Principal investigator, Orthopaedic Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289834
- Sponsor's protocol ID
- VEK20100112
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2010
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.
PubMed 36422666
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Migration (RSA) and Bone Density (DEXA) Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement in Fixation of a Smooth vs. a Fine-blasted Femoral Stem. A Prospective Randomized Study on Primary Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT01289834
- Acronym / sponsor ID
- VEK20100112
- Conditions
- Hip Arthritis
- Keywords
- RSA, Bone Cement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Study start
- Aug 2010 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 4 Feb 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 purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).
Detailed description
A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.
- 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
- 25 CPT femoral stems fixed with Palacos Bone Cement.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hi-Fatigue Bone Cement | Active comparator | Device: Hi-Fatigue Bone CementCPT femoral stems fixed with Hi-Fatigue Bone Cement |
| Palacos Bone Cement | Active comparator | Device: Palacos Bone CementCPT femoral stems fixed with Palacos Bone Cement |
Who may qualify
- Ages
- 71 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- primary hip osteoarthritis
- sufficient bone quality for total hip arthroplasty
- age 71 years and above
- no upper age limit if the patient is capable
- informed and written consent
Key exclusion criteria (23 listed)
- planned bilateral hip surgery
- neuromuscular or vascular disease in the affected leg
- preoperatively not found suitable for a hip arthroplasty
- patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
- fracture sequelae, osteonecrosis or previous extensive hip surgery
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 |
|---|---|---|
| Hi-Fatigue Bone CementHi-Fatigue bone cement is a new development of Aap Biomaterials, GmbH \& Co that has not yet been tested in the clinical setting. Hi-Fatigue has a medium to low viscosity. Laboratory tests confirm Hi-Fatigue bone cement to have properties equivalent to or better than the golden standard bone cement" Palacos. Hi-Fatigue is to be used without pre-chilling. When mixed at a room temperature of 21°C Hi-Fatigue has a low initial viscosity improving mixing and theoretically reducing the porosity of the cured cement. | Device | Hi-Fatigue Bone Cement |
| Palacos Bone CementPalacos Bone Cement has been used for 48 years and has a good reputation as the "gold standard" among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing | Device | Palacos Bone Cement |
Primary outcome
Femoral component migration (roentgen stereo photogrammetric analysis - RSA)
Time frame: 2 years
Migration of the femoral component is measured over time and in respect to the femur bone.
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 18 Apr 2024.
- Derived from this study: PubMed 36422666Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23.
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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.
Kjeld Soballe, Professor MD principal investigator
Orthopaedic Center, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hi-Fatigue Bone Cement and Palacos Bone Cement in people with Hip Arthritis, run by University of Aarhus 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 6 inclusion and 23 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 18 Apr 2024. 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?
Femoral component migration (roentgen stereo photogrammetric analysis - RSA) (time frame: 2 years). 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 NCT01289834, 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 18 Apr 2024.