Osteoarthritis of HipNCT02263209
Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
A study testing Bioguard Group in people with Osteoarthritis of Hip, run by Zimmer Biomet at 1 site in United Kingdom.
Trial summary
Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis of Hip
- What is being tested?
- Bioguard Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to May 2025
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible for cementless primary total hip arthroplasty according to the Surgical Technique brochure (Appendix 10): "The Taperloc Porous Primary Hip and Exceed ABT Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery of non inflammatory degenerative joint disease."
- Under 80 and over 40 years of age
- A pre-operative level of pain and function the same as for conventional joint replacement.
- A likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
- Ability to follow instructions
- Good general health for age
- Willing to return for follow-up evaluations
Who cannot join
- Patients aged over 80 and under 40 years
- Known allergy to any antibiotics
- Active infection
- Revision arthroplasty
- Marked bone loss which could preclude or compromise adequate fixation of the device
- Uncooperative subjects
Show all 13Show fewer
- Parkinson's Disease
- Vascular insufficiency of the affected limb, which could compromise bony ingrowth/implant fixation, i.e., diabetes.
- Severe instability or deformity of the ligaments and/or surrounding soft tissue which may preclude stability of the device
- Pregnancy
- BMI > 40
- Use of immunosuppressive drugs
- Women of child bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
Read the detailed description
Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
- Conditions
- Osteoarthritis of Hip
- Being tested
- Bioguard Group, Control Group
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioguard GroupDevice
Also called Bioguard device
Patients randomised to receive the study investigative device will receive a Bioguard implant
Control GroupDevice
Also called Exceed Taperlock
Patients randomised to receive the control device will receive a Exceed Taperlock implant
| Study group | Role | What they receive |
|---|---|---|
| Bioguard Group | Experimental | Randomised study to either Bioguard or control stock Receives: Device: Bioguard Group |
| Control Group | Active comparator | Randomised study to either Bioguard or control stock Receives: Device: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in normalised peri-implant BMD as measured by DXA
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2015
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of HipStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudheer Karlakki, MD, Principal investigator, RJAH, Oswestry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263209
- Sponsor's protocol ID
- BMETEU.CR.EU77
- Status last verified
- Aug 2024
- First submitted
- 8 Oct 2014
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Investigation to Determine the Safety of Taperloc Stems With BioGuard Coating and Exceed ABT Taperfit Acetabular Cups With BioGuard Coating When Used in Cementless Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02263209
- Acronym / sponsor ID
- BMETEU.CR.EU77
- Conditions
- Osteoarthritis of Hip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 13 Oct 2014 (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.
Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
Detailed description
Bioguard Safety Study: Prospective clinical investigation to determine the safety of Taperloc stems with BioGuard coating and Exceed ABT Taperfit acetabular cups with BioGuard coating when used in cementless total hip arthroplasty
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioguard Group | Experimental | Device: Bioguard GroupRandomised study to either Bioguard or control stock |
| Control Group | Active comparator | Device: Control GroupRandomised study to either Bioguard or control stock |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eligible for cementless primary total hip arthroplasty according to the Surgical Technique brochure (Appendix 10): "The Taperloc Porous Primary Hip and Exceed ABT Taperfit Prostheses are marketed for non-cemented use in skeletally mature patients undergoing primary hip replacement surgery of non inflammatory degenerative joint disease."
- Under 80 and over 40 years of age
- A pre-operative level of pain and function the same as for conventional joint replacement.
- A likelihood of obtaining relief of pain and improved function
- Full skeletal maturity
Key exclusion criteria (13 listed)
- Patients aged over 80 and under 40 years
- Known allergy to any antibiotics
- Active infection
- Revision arthroplasty
- Marked bone loss which could preclude or compromise adequate fixation of the device
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 |
|---|---|---|
| Bioguard GroupAlso: Bioguard devicePatients randomised to receive the study investigative device will receive a Bioguard implant | Device | Bioguard Group |
| Control GroupAlso: Exceed TaperlockPatients randomised to receive the control device will receive a Exceed Taperlock implant | Device | Control Group |
Primary outcome
Change in normalised peri-implant BMD as measured by DXA
Time frame: 6 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis of Hip
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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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.
Sudheer Karlakki, MD principal investigator
RJAH, Oswestry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioguard Group in people with Osteoarthritis of Hip, run by Zimmer Biomet at 1 site in United Kingdom.
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 8 inclusion and 13 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 16 Aug 2024. 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 United Kingdom. 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?
Change in normalised peri-implant BMD as measured by DXA (time frame: 6 months post operative). 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 16 Aug 2024.