Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Claus Varnum, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01420900
First received: August 19, 2011
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.

Condition Intervention
Hip Arthrosis
Device: THA with ABG II / Trident
Device: THA with CLS / Trilogy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: A Prospective, Blinded, Randomized Clinical Trial of Influence of Component Design

Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • All noises from THA [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Life quality [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 204
Study Start Date: September 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABG II / Trident Device: THA with ABG II / Trident
Surgery with total hip arthroplasty in the form of ABG II / Trident
Active Comparator: CLS / Trilogy Device: THA with CLS / Trilogy
Surgery with total hip arthroplasty in the form of CLS / Trilogy

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients scheduled for uncemented THA under the age of 65 years.

Exclusion Criteria:

  • Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
  • Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
  • Severely impaired level of function due to other physical deficiencies than the hip.
  • Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
  • Earlier primary THA or revision THA in the contralateral hip.
  • Pathology requiring another prosthesis concept than the below mentioned.
  • Body mass index greater than 35.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420900

Locations
Denmark
Department of Orthopedic Surgery, Vejle Hospital
Vejle, Denmark
Sponsors and Collaborators
Vejle Hospital
  More Information

Responsible Party: Claus Varnum, MD, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01420900     History of Changes
Other Study ID Numbers: man2if 
Study First Received: August 19, 2011
Last Updated: November 1, 2016
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on December 07, 2016