OsteonecrosisNCT00913679
A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty
A study testing Surgical approach (ReCap Hip Resurfacing System) in people with Osteonecrosis and Femoral Neck Fracture, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Osteonecrosis, Femoral Neck Fracture, Implant Failure
- What is being tested?
- Surgical approach (ReCap Hip Resurfacing System)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2008to Nov 2020
- 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 30 to 60 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;
- Age 30 to 60 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 postoperatively;
- Fracture sequelae;
- Females at risk of pregnancy, no safe contraceptives;
- Severe hip dysplasia;
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- Sequelae from hip disease in childhood;
- Medicine with large effect on bone density, K vitamin antagonists, loop-diuretics;
- Alcoholism, females over 14 units per week, males over 21 units per week; AVN;
- Osteoporosis.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Orthopaedic Surgery, Tage-Hansens Gade 2
Aarhus C, Aarhus County, 8000
About this study
Official title: A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty
The purpose of the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.
Read the detailed description
BACKGROUND:
6700 total hip replacements are performed each year in Denmark due to osteoarthritis. Young patients sustain a substantial risk of early implant failure due to high-activity daily living, and among patients younger than 55 years at surgery 20 percent need revision surgery within ten years. Revision surgery is more complicated than primary surgery and associated with decreased implant longevity due to decreased bone stock. Resurfacing hip arthroplasty (RHA), restores the anatomy of the hip as only the articulating joint surfaces are replaced, and thus more bone is left to ensure a better opportunity of successful revision surgery later on. The clinical midterm evaluation of RHA survival is promising, but two major complications leading to early revision, namely osteonecrosis and femoral neck fracture, has raised concern regarding the influence of surgical technique on the vascularity of the femoral head. RHA is commonly performed through a posterolateral surgical approach. By this technique muscle tendons are spilt resulting in decreased patient mobility for several weeks after surgery, but more importantly, the blood supply is compromised as a large artery has to be ligated. This is speculated to decrease the blood supply to femoral head and neck and thereby increase the risk of osteonecrosis, femoral neck fracture, and implant failure. With a new surgical technique facilitating an anterolateral approach to the hip joint the blood supply is left intact as well as the muscle tendons.
HYPOTHESIS:
An anterolateral surgical approach in resurfacing hip arthroplasty will 1) preserve the blood supply to the femoral head and neck and improve implant longevity, and 2) spare the muscle tendons and ease patient recovery.
METHOD and FACILITIES:
50 patients, aged 30 to 60 years, with osteoarthrosis of the hip will be randomised to a RHA inserted by either an anterolateral or a posterolateral surgical approach. Primary points of evaluation are 1) blood supply to the femoral head and neck measured intraoperatively by Laser Doppler flowmetry and postoperatively by microdialysis established during surgery. Secondary points of evaluation are 1) implant fixation measured by radiostereometric analysis (RSA), and 2) periprosthetic bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA), 3) gait analysis and 4) clinical scores of function, pain and activities of daily living (Harris Hip Score , Visual Analogue Scale).
- Conditions
- Osteonecrosis, Femoral Neck Fracture, Implant Failure
- Being tested
- Surgical approach (ReCap Hip Resurfacing System)
- Keywords
- osteonecrosis, femoral neck fracture, implant fixation, implant failure, periprosthetic bone mineral density, gait function, gait analysis, patient recovery
- Medical subject headings
- Osteonecrosis, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical approach (ReCap Hip Resurfacing System)Procedure or surgery
Also called ReCap Hip Resurfacing System
two different surgical approaches in hip resurfacing arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Posterior approach | Active comparator | Posterior surgical approach in hip resurfacing arthroplasty Receives: Procedure: Surgical approach (ReCap Hip Resurfacing System) |
| Anterolateral approach | Active comparator | Anterolateral surgical approach in hip resurfacing arthroplasty Receives: Procedure: Surgical approach (ReCap Hip Resurfacing System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
femoral head blood flow, evaluated by Laser Doppler Flowmetry
Measured: during surgery
femoral head metabolism, evaluated by microdialysis
Measured: 3 days
Secondary outcomes (4)
implant fixation, evaluated by RSA (radiostereogrammetric analysis)
Measured: postoperatively; 3 months; 1,2 and 5 years
periprosthetic bone mineral density, evaluated by DEXA
Measured: pre- and postoperatively; 1 and 2 years
gait function, evaluated by gait analysis
Measured: preoperatively; 3 months and 1 year
patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale
Measured: preoperatively and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study start1 Nov 2008
- Primary completion20 Feb 2017
- Study completionNov 2020
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 OsteonecrosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913679
- Sponsor's protocol ID
- 20070082
- Status last verified
- Dec 2022
- First submitted
- 2 Jun 2009
- Last updated
- 15 Dec 2022
- 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 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Surgical Techniques to Preserve the Bony Supply and Improve Implant Longevity in Hip Resurfacing Arthroplasty
- ClinicalTrials.gov ID
- NCT00913679
- Acronym / sponsor ID
- 20070082
- Conditions
- Osteonecrosis, Femoral Neck Fracture, Implant Failure
- Keywords
- osteonecrosis, femoral neck fracture, implant fixation, implant failure, periprosthetic bone mineral density, gait function, gait analysis, patient recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Zimmer Biomet
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 4 Jun 2009 (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 the study is to compare two different surgical techniques in hip resurfacing arthroplasty (RHA), comparing bloodflow and metabolism in the femoral head, as well as implant migration, periprosthetic bone mineral density, gait function and patient recovery.
Detailed description
BACKGROUND:
6700 total hip replacements are performed each year in Denmark due to osteoarthritis. Young patients sustain a substantial risk of early implant failure due to high-activity daily living, and among patients younger than 55 years at surgery 20 percent need revision surgery within ten years. Revision surgery is more complicated than primary surgery and associated with decreased implant longevity due to decreased bone stock. Resurfacing hip arthroplasty (RHA), restores the anatomy of the hip as only the articulating joint surfaces are replaced, and thus more bone is left to ensure a better opportunity of successful revision surgery later on. The clinical midterm evaluation of RHA survival is promising, but two major complications leading to early revision, namely osteonecrosis and femoral neck fracture, has raised concern regarding the influence of surgical technique on the vascularity of the femoral head. RHA is commonly performed through a posterolateral surgical approach. By this technique muscle tendons are spilt resulting in decreased patient mobility for several weeks after surgery, but more importantly, the blood supply is compromised as a large artery has to be ligated. This is speculated to decrease the blood supply to femoral head and neck and thereby increase the risk of osteonecrosis, femoral neck fracture, and implant failure. With a new surgical technique facilitating an anterolateral approach to the hip joint the blood supply is left intact as well as the muscle tendons.
HYPOTHESIS:
An anterolateral surgical approach in resurfacing hip arthroplasty will 1) preserve the blood supply to the femoral head and neck and improve implant longevity, and 2) spare the muscle tendons and ease patient recovery.
METHOD and FACILITIES:
50 patients, aged 30 to 60 years, with osteoarthrosis of the hip will be randomised to a RHA inserted by either an anterolateral or a posterolateral surgical approach. Primary points of evaluation are 1) blood supply to the femoral head and neck measured intraoperatively by Laser Doppler flowmetry and postoperatively by microdialysis established during surgery. Secondary points of evaluation are 1) implant fixation measured by radiostereometric analysis (RSA), and 2) periprosthetic bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA), 3) gait analysis and 4) clinical scores of function, pain and activities of daily living (Harris Hip Score , Visual Analogue Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior approach | Active comparator | Procedure: Surgical approach (ReCap Hip Resurfacing System)Posterior surgical approach in hip resurfacing arthroplasty |
| Anterolateral approach | Active comparator | Procedure: Surgical approach (ReCap Hip Resurfacing System)Anterolateral surgical approach in hip resurfacing arthroplasty |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 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;
- Age 30 to 60 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 postoperatively;
- 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 |
|---|---|---|
| Surgical approach (ReCap Hip Resurfacing System)Also: ReCap Hip Resurfacing Systemtwo different surgical approaches in hip resurfacing arthroplasty | Procedure or surgery | Anterolateral approach, Posterior approach |
Primary outcome
femoral head blood flow, evaluated by Laser Doppler Flowmetry
Time frame: during surgery
femoral head metabolism, evaluated by microdialysis
Time frame: 3 days
4 secondary outcomes
implant fixation, evaluated by RSA (radiostereogrammetric analysis)
Time frame: postoperatively; 3 months; 1,2 and 5 years
periprosthetic bone mineral density, evaluated by DEXA
Time frame: pre- and postoperatively; 1 and 2 years
gait function, evaluated by gait analysis
Time frame: preoperatively; 3 months and 1 year
patient recovery, evaluated by Harris Hip Score and Visual Analogue Scale
Time frame: preoperatively and 3 months
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 15 Dec 2022.
- 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.
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 Surgical approach (ReCap Hip Resurfacing System) in people with Osteonecrosis and Femoral Neck Fracture, 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 5 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 15 Dec 2022. 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 head blood flow, evaluated by Laser Doppler Flowmetry (time frame: during surgery). The study lists 2 primary outcomes in all. 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 NCT00913679, 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 15 Dec 2022.