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Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Prospective Randomized Double Blinded Clinical Evaluation on HA Coated Dynamic Hip Screws for Trochanteric Femoral Fractures

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00756431
Enrollment
0
Registered
2008-09-22
Start date
2004-01-31
Completion date
2010-06-30
Last updated
2017-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Brief summary

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

Interventions

DEVICEHip Fracture reduction Screw without HA Coating (Hiploc)

Hip Fracture reduction Screw without HA Coating (Hiploc)

DEVICEHip Fracture reduction Screw with HA Coating (Hiploc)

Hip Fracture reduction Screw with HA Coating (Hiploc)

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
Biomet U.K. Ltd.
CollaboratorINDUSTRY
Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with trochanteric femoral fractures

Design outcomes

Primary

MeasureTime frame
Harris Hip Score3months, 6 months

Secondary

MeasureTime frame
DEXA3months, 6 months
RSA3months,6 months
ComplicationsAnytime

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026