CoxarthrosisNCT00318396
Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral
A study testing Bone preparation technique: compaction and Bone preparation technique: conventional technique in people with Coxarthrosis, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial summary
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coxarthrosis
- What is being tested?
- Bone preparation technique: compaction and Bone preparation technique: conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2004to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary arthritis in the hip
- Patients with sufficient bone density to allow uncemented implantation of a femoral component
- Informed patient consent in writing
Who cannot join
- Patients with neuromuscular or vascular disease in the affected leg
- Patients found upon operation to be unsuited for uncemented acetabulum component
- Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
- Patients with fracture sequelae
- Female patients of childbearing capacity
- Hip joint dysplasia
- Sequelae to previous hip joint disorder in childhood
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital
Farsø, Northern Jutland
About this study
Official title: Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.
Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.
- Conditions
- Coxarthrosis
- Being tested
- Bone preparation technique: compaction, Bone preparation technique: conventional technique
- Keywords
- THA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone preparation technique: compactionProcedure or surgery
Also called No other names.
The bone is pressed very hard together before implantation of femoral component.
Bone preparation technique: conventional techniqueProcedure or surgery
Also called No other names.
Bone is broached before implantation of femoral component.
| Study group | Role | What they receive |
|---|---|---|
| Compaction | Experimental | The bone is pressed very hard together before implantation of femoral component. Receives: Procedure: Bone preparation technique: compaction |
| Conventional technique | Active comparator | The bone is broached before implantation of femoral component. Receives: Procedure: Bone preparation technique: conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine a possible difference in density of bones around implantation of femoral component.
A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startJun 2004
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soeren Kold, MD, Principal investigator, Northern Orthopaedic DivisionKjeld Soeballe, MD, Prof., Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318396
- Sponsor's protocol ID
- ON-04-002a-SKO
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2006
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compaction Femur Total Hip Arthroplasty (THA) Uni-lateral
- ClinicalTrials.gov ID
- NCT00318396
- Acronym / sponsor ID
- ON-04-002a-SKO
- Conditions
- Coxarthrosis
- Keywords
- THA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Apr 2006 (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.
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction.
Hypothesis: Compaction results in significantly less stem migration [evaluated by radiostereometric analysis (RSA)], less peri-prosthetic bone mineral density (BMD) loss [evaluated by dual energy x-ray absorptiometry (DEXA)], and a higher Harris hip score after two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compaction | Experimental | Procedure: Bone preparation technique: compactionThe bone is pressed very hard together before implantation of femoral component. |
| Conventional technique | Active comparator | Procedure: Bone preparation technique: conventional techniqueThe bone is broached before implantation of femoral component. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary arthritis in the hip
- Patients with sufficient bone density to allow uncemented implantation of a femoral component
- Informed patient consent in writing
Key exclusion criteria (7 listed)
- Patients with neuromuscular or vascular disease in the affected leg
- Patients found upon operation to be unsuited for uncemented acetabulum component
- Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study
- Patients with fracture sequelae
- Female patients of childbearing capacity
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 |
|---|---|---|
| Bone preparation technique: compactionAlso: No other names.The bone is pressed very hard together before implantation of femoral component. | Procedure or surgery | Compaction |
| Bone preparation technique: conventional techniqueAlso: No other names.Bone is broached before implantation of femoral component. | Procedure or surgery | Conventional technique |
Primary outcome
To examine a possible difference in density of bones around implantation of femoral component.
Time frame: 5 years
A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
Soeren Kold, MD principal investigator
Northern Orthopaedic Division
Kjeld Soeballe, MD, Prof. study director
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 Bone preparation technique: compaction and Bone preparation technique: conventional technique in people with Coxarthrosis, 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 3 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: status not confirmed, as of the sponsor's last update on 12 Apr 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?
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?
To examine a possible difference in density of bones around implantation of femoral component. (time frame: 5 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 12 Apr 2017.