ArthritisNCT00604734
A Prospective Clinical Study On A Total Hip Resurfacing System
A study testing ReCap Total Hip Resurfacing System in people with Arthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in Belgium.
Trial summary
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Avascular Necrosis
- What is being tested?
- ReCap Total Hip Resurfacing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2004to Oct 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a preoperative Total Harris Hip Score of < 70
- Conservative treatment has proven unsuccessful
- Primary hip surgery
- Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- Osteoarthritis
- Avascular necrosis
Show all 13Show fewer
- Legg Perthes
- Rheumatoid Arthritis
- Juvenile Rheumatoid Arthritis
- Systemic Lupus Erythematosus
- Developmental Dysplasia, which does not prevent stable acetabular reconstruction
- Post traumatic arthritis S. Patients at least 18 years of age
- 6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form
Who cannot join
- Patients with a preoperative Total Harris Hip Score of > 70
- Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- Developmental dysplasla, which prevents stable acetabular reconstruction
- Patients with previous Girdlestone procedures
- Patients with above knee amputation of the contralateral and/or ipsilateral leg
Show all 20Show fewer
- Severe osteoarthritis or marked bone loss,which would preclude proper fixation of the prosthetic device(s)
- Active or suspected systemic or localized Infection
- Parkinson's or Alzheimer's Disease
- Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue,which would preclude stability of the prosthesis
- Patients less than 18 years of age
- Patients with condition(s) that may Interfere with the survival of the femoral resurfacing or acetabular replacements or their outcomes,including Paget's Disease, Charcot's Disease, Sickle Cell Anemia or traits Severe osteoporosis compromising bone stock (I.e.Dorr type C bone Lower extremity muscular atrophy Neuromuscular disease
- Patients with a clinical conditions that may limit follow-up,including: immunocompromised conditions, hepatitis, active tuberculosis, neoplastic disease, chronic renal failure, organ transplant recipients, known terminal disease process
- Patients with a "fused"hip
- Patients with metal allergy or hypersensitivity
- Participation in a study of any investigational product (drug or device) within the past 12 months
- Prisoners,known drug or alcohol abuser,or mentally incompetent individuals
- Systemic steroids within 6 months
- Patients with a known malignancy
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Read the detailed description
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
- Total Harris hip score
- Device revisions or removals
Secondary endpoints:
- Total Harris hip score
- Radiographic changes as evidenced by:
- Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
- Conditions
- Arthritis, Avascular Necrosis
- Being tested
- ReCap Total Hip Resurfacing System
- Medical subject headings
- Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCap Total Hip Resurfacing SystemDevice
Also called Total hip resurfacing, ReCap
This is a hip resurfacing system.
| Study group | Role | What they receive |
|---|---|---|
| ReCap | Other | ReCap Total Hip Resurfacing System Receives: Device: ReCap Total Hip Resurfacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Measured: 2 years postoperative
Secondary outcomes (1)
Complications
Measured: Anytime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startOct 2004
- Primary completionOct 2007
- Study completionOct 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jo De Schepper, MD, Principal investigator, AZ Nikolaas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604734
- Sponsor's protocol ID
- EU-8
- Status last verified
- Feb 2019
- First submitted
- 23 Dec 2007
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study On A Total Hip Resurfacing System
- ClinicalTrials.gov ID
- NCT00604734
- Acronym / sponsor ID
- EU-8
- Conditions
- Arthritis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 30 Jan 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 prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Detailed description
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
- Total Harris hip score
- Device revisions or removals
Secondary endpoints:
- Total Harris hip score
- Radiographic changes as evidenced by:
- Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReCap | Other | Device: ReCap Total Hip Resurfacing SystemReCap Total Hip Resurfacing System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with a preoperative Total Harris Hip Score of < 70
- Conservative treatment has proven unsuccessful
- Primary hip surgery
- Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
- 6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form
Key exclusion criteria (20 listed)
- Patients with a preoperative Total Harris Hip Score of > 70
- Previous prosthetic hip replacement device (including other surface arthroplasty, endoprosthesis,etc) in the operative hip
- Contralateral hip prosthesis (total hip replacement or surface replacement),including staged or simultaneous procedures
- Developmental dysplasla, which prevents stable acetabular reconstruction
- Patients with previous Girdlestone procedures
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 |
|---|---|---|
| ReCap Total Hip Resurfacing SystemAlso: Total hip resurfacing, ReCapThis is a hip resurfacing system. | Device | ReCap |
Primary outcome
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time frame: 2 years postoperative
1 secondary outcome
Complications
Time frame: Anytime
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 Feb 2019.
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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.
Jo De Schepper, MD principal investigator
AZ Nikolaas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReCap Total Hip Resurfacing System in people with Arthritis and Avascular Necrosis, run by Zimmer Biomet at 1 site in Belgium.
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 13 inclusion and 20 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 Feb 2019. 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 Belgium. 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?
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation (time frame: 2 years postoperative). 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 Feb 2019.