Intertrochanteric FracturesNCT05677061
Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
A study testing Dynamic Hip Screw with HA-coating (Hiploc) and Dynamic Hip Screw without coating (Hiploc) in people with Intertrochanteric Fractures, run by University of Aarhus.
Trial summary
Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intertrochanteric Fractures
- What is being tested?
- Dynamic Hip Screw with HA-coating (Hiploc) and Dynamic Hip Screw without coating (Hiploc)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Feb 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
- able to speak Danish
- able to complete the postoperative controls
- written consent
Who cannot join
- unable to follow standard hip fracture regime
- were breastfeeding
- pregnant
- terminal disease
- in need of open fracture reduction
- in need of DHS plate with an angle different from 135 degrees
Show all 9Show fewer
- insertion of fewer than 3 tantalum beads in the femoral head (for RSA)
- TAD >20mm in two dimensions in the first postoperative x-ray
- fracture displacement >20mm in two dimensions in the first postoperative x-ray
About this study
Evaluated whether HA coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures
Read the detailed description
Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.
- Conditions
- Intertrochanteric Fractures
- Being tested
- Dynamic Hip Screw with HA-coating (Hiploc), Dynamic Hip Screw without coating (Hiploc)
- Keywords
- Stable Fractures (Evans I, II, IV)
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Hip Screw with HA-coating (Hiploc)Device
During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture
Dynamic Hip Screw without coating (Hiploc)Device
During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture
| Study group | Role | What they receive |
|---|---|---|
| HA-coated | Experimental | Hydroxyapatite coating on Screw thread of DHS Receives: Device: Dynamic Hip Screw with HA-coating (Hiploc) |
| NON-coated | Active comparator | No coating on Screw thread of DHS Receives: Device: Dynamic Hip Screw without coating (Hiploc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lag Screw migration measured as y-translation (mm)
Lag screw migration measured as y-translation (mm) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up
Measured: 6 months PO
Secondary outcomes (7)
Lag screw migration measured as translations in mm
Lag screw migration measured as translations in mm along the three orthogonal axes (x and z) and rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed translations (total translation) and summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up
Measured: 6 months PO
Lag screw migration measured as rotations in degrees
Lag screw migration measured as rotations in degrees about the three orthogonal axes (x, y and z) in addition to the summed summed rotations (total rotation) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up
Measured: 6 months PO
Radiological measurements
TAD AP+LAT, fracture reposition AP+LAT (mm)
Measured: 6 months
Clinical outcomes - HHS
Change in Harris Hip Score (HHS) measured as a scale from 0 (worst) to 100 (best) from pre-operative til 6 months postoperative
Measured: 6 months PO
Clinical outcomes - NMS
New Mobility Score measured on a scale from 0 (no mobility function) to 9 (full independent mobility function) preoperative
Measured: Preoperative
Clinical outcomes - Leg Lengths difference
Leg Length difference in cm at 6 months follow-up indicate fracture impaction
Measured: 6 months
Clinical outcomes - TUG test
Timed Up and Go Test (TUG) at 6 months follow-up (a score less than 20 seconds indicate mobility independence)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startApr 2008
- Primary completionAug 2013
- Study completionFeb 2023
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 Intertrochanteric FracturesStudies 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
- Model description
- Patient and Assessor blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitalsenheden Vest, Hvidovre University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677061
- Sponsor's protocol ID
- H-KF-298036
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not possible due til GDPR restrictions
Publications
Krogh AC, Thillemann JK, Hansen TB, Holck K, Kristensen MT, Palm H, Stilling M. No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis. J Orthop Surg Res. 2023 Sep 14;18(1):686. doi: 10.1186/s13018-023-04170-0.
PubMed 37710269
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures
- ClinicalTrials.gov ID
- NCT05677061
- Acronym / sponsor ID
- H-KF-298036
- Conditions
- Intertrochanteric Fractures
- Keywords
- Stable Fractures (Evans I, II, IV)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Hospitalsenheden Vest, Hvidovre University Hospital
- Study start
- Apr 2008 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 10 Jan 2023 (actual)
- 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 fixation of the screw in trochanteric femoral fractures
Detailed description
Randomised study to determine the effect of HA coating on the stability of dynamic Hip screws used to stabilize femoral neck fractures. Stability of the screw will be determined by RSA measurements. Additionally the fracture stability will be evaluated by RSA measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patient and Assessor blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| HA-coated | Experimental | Device: Dynamic Hip Screw with HA-coating (Hiploc)Hydroxyapatite coating on Screw thread of DHS |
| NON-coated | Active comparator | Device: Dynamic Hip Screw without coating (Hiploc)No coating on Screw thread of DHS |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with stable intertrochanteric femoral fractures (Evans I, II, IV)
- able to speak Danish
- able to complete the postoperative controls
- written consent
Key exclusion criteria (9 listed)
- unable to follow standard hip fracture regime
- were breastfeeding
- pregnant
- terminal disease
- in need of open fracture reduction
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 |
|---|---|---|
| Dynamic Hip Screw with HA-coating (Hiploc)During surgery for pertrochanteric hip fracture a lag screw with hydroxyapatite coating on the screw thread was used to fix the fracture | Device | HA-coated |
| Dynamic Hip Screw without coating (Hiploc)During surgery for pertrochanteric hip fracture a lag screw with no coating on the screw thread was used to fix the fracture | Device | NON-coated |
Primary outcome
Lag Screw migration measured as y-translation (mm)
Time frame: 6 months PO
Lag screw migration measured as y-translation (mm) with respect to the femoral head/neck fracture segment using marker-based radiostereometry (ModelBased RSA vs 4.2 or newer) until 6 months follow-up
7 secondary outcomes
Lag screw migration measured as translations in mm
Time frame: 6 months PO
Lag screw migration measured as rotations in degrees
Time frame: 6 months PO
Radiological measurements
Time frame: 6 months
Clinical outcomes - HHS
Time frame: 6 months PO
Clinical outcomes - NMS
Time frame: Preoperative
Clinical outcomes - Leg Lengths difference
Time frame: 6 months
Clinical outcomes - TUG test
Time frame: 6 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 9 Feb 2023.
- Derived from this study: PubMed 37710269Krogh AC, Thillemann JK, Hansen TB, Holck K, Kristensen MT, Palm H, Stilling M. No effect of hydroxyapatite-coated sliding hip screw threads on screw migration in the femoral head/neck of pertrochanteric fractures: a randomized controlled trial using radiostereometric analysis. J Orthop Surg Res. 2023 Sep 14;18(1):686. doi: 10.1186/s13018-023-04170-0.
- Individual participant dataSharing planned: No. Not possible due til GDPR restrictions
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Hip Screw with HA-coating (Hiploc) and Dynamic Hip Screw without coating (Hiploc) in people with Intertrochanteric Fractures, run by University of Aarhus.
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 4 inclusion and 9 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 9 Feb 2023. 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 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?
Lag Screw migration measured as y-translation (mm) (time frame: 6 months PO). 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 NCT05677061, 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 9 Feb 2023.