ArthritisNCT00750984
A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
A study testing Anterolateral approach, Posterior approach and ReCap Total Hip Resurfacing in people with Arthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in Denmark.
Trial summary
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System. Read more about this study
- Who is it for?
- Ages 29 to 61 years
- Conditions the study is for
- Arthritis, Avascular Necrosis
- What is being tested?
- Anterolateral approach, Posterior approach and ReCap Total Hip Resurfacing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2008to Feb 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 29 to 61 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary hip OA
- Secondary hip OA due to mild and moderate acetabular dysplasia
- Sufficient bone quality for cementless acetabular component
- Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
- >29 years
- <61 years
Who cannot join
- Neuromuscular or vascular diseases in affected leg
- Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
- Need of NSAID post-operatively
- Fracture sequelae
- Females at risk of pregnancy (no safe contraceptives)
- Severe hip dysplasia
Show all 10Show fewer
- Sequelae from hip disease in childhood
- Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
- Alcoholism (females > 14 units per week, males > 21 units per week) AVN
- Osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Read the detailed description
Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:
- Less bone resection, less complicated revision surgery.
- Reduced stress shielding of the femur.
- Lower incidence of hip dislocations.
- Walking function improved by change in mobilisation regime and operative technique.
- Risk of femoral neck fracture is reduced by preoperative measurement of bone density.
- Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.
- Conditions
- Arthritis, Avascular Necrosis
- Being tested
- Anterolateral approach, Posterior approach, ReCap Total Hip Resurfacing
- Medical subject headings
- Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterolateral approachProcedure or surgery
The anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method.
Posterior approachProcedure or surgery
The posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head.
ReCap Total Hip ResurfacingDevice
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
ReCap Total Hip ResurfacingDevice
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System. Receives: Procedure: Anterolateral approach; Device: ReCap Total Hip Resurfacing |
| 2 | Active comparator | This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System. Receives: Procedure: Posterior approach; Device: ReCap Total Hip Resurfacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA
Measured: 1 week, 3 months, 1 year, 2 years, 5 years
Secondary outcomes (5)
Harris Hip Score
Measured: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
Microdialysis
Measured: 1 week
Conventional X-ray
Measured: 1 week
Gait Analysis
Measured: 1 week, 3 months, 1 year
DEXA scan
Measured: Pre-operatively, 1 week, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2013
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Thomas Pryno, MD, Principal investigator, Aarhus University HospitalKjeld Soeballe, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750984
- Sponsor's protocol ID
- BMETEU.CR.EU9
- Status last verified
- Sep 2016
- First submitted
- 10 Sep 2008
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
- ClinicalTrials.gov ID
- NCT00750984
- Acronym / sponsor ID
- BMETEU.CR.EU9
- Conditions
- Arthritis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Aarhus University Hospital
- Study start
- Sep 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 11 Sep 2008 (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 study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
Detailed description
Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:
- Less bone resection, less complicated revision surgery.
- Reduced stress shielding of the femur.
- Lower incidence of hip dislocations.
- Walking function improved by change in mobilisation regime and operative technique.
- Risk of femoral neck fracture is reduced by preoperative measurement of bone density.
- Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Anterolateral approach, Device: ReCap Total Hip ResurfacingThis arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System. |
| 2 | Active comparator | Procedure: Posterior approach, Device: ReCap Total Hip ResurfacingThis arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System. |
Who may qualify
- Ages
- 29 to 61 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primary hip OA
- Secondary hip OA due to mild and moderate acetabular dysplasia
- Sufficient bone quality for cementless acetabular component
- Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
- >29 years
Key exclusion criteria (10 listed)
- Neuromuscular or vascular diseases in affected leg
- Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
- Need of NSAID post-operatively
- Fracture sequelae
- Females at risk of pregnancy (no safe contraceptives)
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 |
|---|---|---|
| Anterolateral approachThe anterolateral approach is performed with the patient positioned on the side. The blood supply to the femoral neck from the medial circumflex artery is regarded preserved by this surgical method. | Procedure or surgery | 1 |
| Posterior approachThe posterior approach is performed with the patient positioned on the side. The medial circumflex artery is cut at the lower border of the short external rotators risking a compromised blood supply to the femoral head. | Procedure or surgery | 2 |
| ReCap Total Hip ResurfacingThis arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System. | Device | 1 |
| ReCap Total Hip ResurfacingThis arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System. | Device | 2 |
Primary outcome
RSA
Time frame: 1 week, 3 months, 1 year, 2 years, 5 years
5 secondary outcomes
Harris Hip Score
Time frame: Pre-operatively, 1 week, 6 weeks, 3 months, 1 year
Microdialysis
Time frame: 1 week
Conventional X-ray
Time frame: 1 week
Gait Analysis
Time frame: 1 week, 3 months, 1 year
DEXA scan
Time frame: Pre-operatively, 1 week, 1 year, 2 years
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 11 Jan 2018.
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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.
Thomas Pryno, MD principal investigator
Aarhus University Hospital
Kjeld Soeballe, MD, PhD principal investigator
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 Anterolateral approach, Posterior approach and ReCap Total Hip Resurfacing in people with Arthritis and Avascular Necrosis, run by Zimmer Biomet 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 10 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 11 Jan 2018. 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?
RSA (time frame: 1 week, 3 months, 1 year, 2 years, 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 11 Jan 2018.