OsteoarthritisNCT00756431
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
A study testing Hip Fracture reduction Screw without HA Coating (Hiploc) and Hip Fracture reduction Screw with HA Coating (Hiploc) in people with Osteoarthritis, run by Zimmer Biomet.
Trial summary
Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Hip Fracture reduction Screw without HA Coating (Hiploc) and Hip Fracture reduction Screw with HA Coating (Hiploc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jun 2010
- 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 trochanteric femoral fractures
Who cannot join
None listed.
About this study
Official title: Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures
Read the detailed description
Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements
- Conditions
- Osteoarthritis
- Being tested
- Hip Fracture reduction Screw without HA Coating (Hiploc), Hip Fracture reduction Screw with HA Coating (Hiploc)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Fracture reduction Screw without HA Coating (Hiploc)Device
Also called Hiploc
Hip Fracture reduction Screw without HA Coating (Hiploc)
Hip Fracture reduction Screw with HA Coating (Hiploc)Device
Also called Hiploc
Hip Fracture reduction Screw with HA Coating (Hiploc)
| Study group | Role | What they receive |
|---|---|---|
| Screw without HA Coating (Hiploc) | Active comparator | Not described Receives: Device: Hip Fracture reduction Screw without HA Coating (Hiploc) |
| Screw with HA Coating (Hiploc) | Experimental | Not described Receives: Device: Hip Fracture reduction Screw with HA Coating (Hiploc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: 3months, 6 months
Secondary outcomes (3)
DEXA
Measured: 3months, 6 months
RSA
Measured: 3months,6 months
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 posted22 Sep 2008 (estimated)
- Study startJan 2004
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: No data so far
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital, Biomet U.K. Ltd.
- Responsible party
- Sponsor
- Investigators
- Hendrik Palm, MD, Principal investigator, Hvidovre Univ. Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756431
- Sponsor's protocol ID
- BMET UK 06
- Status last verified
- Jun 2017
- First submitted
- 19 Sep 2008
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
- ClinicalTrials.gov ID
- NCT00756431
- Acronym / sponsor ID
- BMET UK 06
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No data so far
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Hvidovre University Hospital, Biomet U.K. Ltd.
- Study start
- Jan 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 22 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.
Evaluated whether HA coated dynamic hip screws can improve the surgical results in trochanteric femoral fractures
Detailed description
Randomised study to determine the effect of HA coating on the stability of lag screws used to reduce femoral neck fractures. Stability of the screw will be determined by RSA measurements. The effect of the HA coating on bone remodeling will be determined by DEXA measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screw without HA Coating (Hiploc) | Active comparator | Device: Hip Fracture reduction Screw without HA Coating (Hiploc) |
| Screw with HA Coating (Hiploc) | Experimental | Device: Hip Fracture reduction Screw with HA Coating (Hiploc) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with trochanteric femoral fractures
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Hip Fracture reduction Screw without HA Coating (Hiploc)Also: HiplocHip Fracture reduction Screw without HA Coating (Hiploc) | Device | Screw without HA Coating (Hiploc) |
| Hip Fracture reduction Screw with HA Coating (Hiploc)Also: HiplocHip Fracture reduction Screw with HA Coating (Hiploc) | Device | Screw with HA Coating (Hiploc) |
Primary outcome
Harris Hip Score
Time frame: 3months, 6 months
3 secondary outcomes
DEXA
Time frame: 3months, 6 months
RSA
Time frame: 3months,6 months
Complications
Time frame: Anytime
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Hendrik Palm, MD principal investigator
Hvidovre Univ. Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Hip Fracture reduction Screw without HA Coating (Hiploc) and Hip Fracture reduction Screw with HA Coating (Hiploc) in people with Osteoarthritis, run by Zimmer Biomet.
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 1 inclusion and 0 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: withdrawn, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: 3months, 6 months). 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 Jun 2017.