CoxarthrosisNCT00317889
Compaction Total Hip Arthroplasty (THA) Bilateral
A study testing Bone preparation technique: compaction and Bone preparation technique: broaching 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 porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side. 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: broaching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- May 2001to Sep 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.
About this study
Official title: Compaction THA Bilateral
This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.
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: broaching
- 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.
Bone preparation technique: broachingProcedure or surgery
Also called No other names.
| Study group | Role | What they receive |
|---|---|---|
| Compaction | Experimental | Compaction technique for femoral bone preparation prior to cementless femoral stem insertion. Receives: Procedure: Bone preparation technique: compaction |
| Broaching | Active comparator | Broaching technique for femoral bone preparation prior to cementless femoral stem insertion. Receives: Procedure: Bone preparation technique: broaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric analysis
Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis
Measured: 5 and 10 years follow-up
Secondary outcomes (1)
Periprosthetic bone mineral density
Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)
Measured: 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startMay 2001
- Primary completionSep 2017
- Study completionSep 2017
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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Kold, MD, Principal investigator, Northern Orthopaedic Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317889
- Sponsor's protocol ID
- ON-04-002b-SKO
- Status last verified
- Dec 2020
- First submitted
- 23 Apr 2006
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compaction THA Bilateral
- ClinicalTrials.gov ID
- NCT00317889
- Acronym / sponsor ID
- ON-04-002b-SKO
- Conditions
- Coxarthrosis
- Keywords
- THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 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 porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side.
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
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compaction | Experimental | Procedure: Bone preparation technique: compactionCompaction technique for femoral bone preparation prior to cementless femoral stem insertion. |
| Broaching | Active comparator | Procedure: Bone preparation technique: broachingBroaching technique for femoral bone preparation prior to cementless femoral stem insertion. |
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. | Procedure or surgery | Compaction |
| Bone preparation technique: broachingAlso: No other names. | Procedure or surgery | Broaching |
Primary outcome
Radiostereometric analysis
Time frame: 5 and 10 years follow-up
Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis
1 secondary outcome
Periprosthetic bone mineral density
Time frame: 5 years follow-up
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 19 Dec 2020.
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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.
Søren Kold, MD principal investigator
Northern Orthopaedic Division
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: broaching 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: finished, as of the sponsor's last update on 19 Dec 2020. 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?
Radiostereometric analysis (time frame: 5 and 10 years follow-up). 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 Dec 2020.