NCT01420900

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

6.2 years

First QC Date

August 19, 2011

Last Update Submit

November 3, 2017

Conditions

Hip Arthrosis

Outcome Measures

Primary Outcomes (1)

  • All noises from THA

    One year

Secondary Outcomes (1)

  • Life quality

    One year

Study Arms (2)

ABG II / Trident

ACTIVE COMPARATOR
Device: THA with ABG II / Trident

CLS / Trilogy

ACTIVE COMPARATOR
Device: THA with CLS / Trilogy

Interventions

THA with ABG II / TridentDEVICE

Surgery with total hip arthroplasty in the form of ABG II / Trident

ABG II / Trident
THA with CLS / TrilogyDEVICE

Surgery with total hip arthroplasty in the form of CLS / Trilogy

CLS / Trilogy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopedic Surgery, Vejle Hospital

Vejle, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

September 1, 2011

Primary Completion

November 3, 2017

Study Completion

November 3, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

DK(1)