Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00757653
• Collaborator: Biomet U.K. Ltd. (Industry)
• Enrollment: 57
• Location: 1
• Arms: 3
• Duration (Months): 74
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Retrieval study and histological examination of BiMetric Femoral Components with hydroxyapatite coatings.

Condition or Disease	Intervention/Treatment	Phase
Femoral Neck Fractures	Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA; Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA; Device: Hip stem with Interloc Titanium surface + Bonemaster H.A	N/A

Detailed Description

A single type of femoral component with 3 different HA coatings will be evaluated in this study. Patients with fractured neck of femur requiring hemi-arthroplasty will be recruited. Safety and performance of the device will be determined by adverse events (device related or non-related), survival and histological exam.

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Retrieval Study and Histological Examination Of A Hip Femoral Components With Hydroxyapatite Coatings
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Stem with plasma sprayed porous Titanium 6Al4V alloy + Plasma sprayed HA	Device: Hip stem with plasma sprayed porous Ti 6Al4V alloy + plasma sprayed HA; Hip stem with plasma sprayed porous Titanium 6Al4V alloy + plasma sprayed HA
Experimental: 2	Device: Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA; Hip stem with plasma spayed porous Titanium 6Al4V alloy + Bonemaster HA
Active Comparator: 3	Device: Hip stem with Interloc Titanium surface + Bonemaster H.A; Hip stem with Interloc Titanium surface + Bonemaster H.A

Outcome Measures

Primary Outcome Measures

1. Adverse Event [Anytime]

Secondary Outcome Measures

1. Histological Exam [Anytime]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Fractured neck of femur requiring hemi-arthroplasty. Selection of subjects for this evaluation should include the following considerations:-.

• 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 .

• No bias to sex.

Exclusion criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	William Harvey Hospital	Ashford	Kent	United Kingdom

Sponsors and Collaborators

• Zimmer Biomet
• Biomet U.K. Ltd.

Investigators

• Principal Investigator: Helmut Zahn, FRCS, William Harvey Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00757653
• Other Study ID Numbers: BMET UK 04
• First Posted: Sep 23, 2008
• Last Update Posted: Jun 20, 2017
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Femoral Neck Fractures

Study Results

No Results Posted as of Jun 20, 2017