Investigation to Determine Safety of Taperloc Stems With BioGuard Coating When Used in Cementless Total Hip Arthroplasty

NCT02263209 | Active Not Recruiting

• 1 other identifier: BMETEU.CR.EU77
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (1)

• Change in normalised peri-implant BMD as measured by DXA

  6 months post operative

Study Arms (2)

Bioguard Group

EXPERIMENTAL

Randomised study to either Bioguard or control stock

Device: Bioguard Group

Control Group

ACTIVE COMPARATOR

Randomised study to either Bioguard or control stock

Device: Control Group

Interventions

Bioguard Group DEVICE

Patients randomised to receive the study investigative device will receive a Bioguard implant

Also known as: Bioguard device

Bioguard Group

Control Group DEVICE

Patients randomised to receive the control device will receive a Exceed Taperlock implant

Also known as: Exceed Taperlock

Control Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

RJAH

Oswestry, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sudheer Karlakki, MD

  RJAH, Oswestry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

GB (1)