NCT02047292

Brief Summary

Pain and reduced function are the most common symptoms of coxarthritis. Pain relief and normal range of motion (ROM) restoration are the objectives of a Total Hip Arthroplasty (THA) procedure. It is recognized that increased head-neck ratio results in increased ROM due to the fact that prosthetic impingement between neck and acetabular liner occurs with wider arcs of motion. This head-neck ratio has been investigated extensively only in vitro (on cadavers or sawbones) or using mathematical modeling in computer simulations. These studies are limited by the lack of soft tissues and muscle activations in the models. This study will clinically assess the effect of prosthetic head diameter on patient capability of performing movements which require extreme arcs of motion of the hip joint. Therefore, the research questions are:

  • What role do soft tissues play in limiting ROM?
  • Can prosthetic impingement really occur in a well positioned THA?
  • Can a bigger head diameter alone reduce the risk of impingement?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

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

Study Start

First participant enrolled

January 1, 2014

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

January 22, 2014

Last Update Submit

February 13, 2020

Conditions

Hip Osteoarthritis

Keywords

Gait analysis3D videofluoroscopyFemoroacetabular impingementNeck-cup impingementHead-neck ratioHip scoresFunctional assessmentCup sizeRange of motionUnilateral PrimarySecondary

Outcome Measures

Primary Outcomes (2)

  • Number of Participants and Hip Joint Positions with the Occurrence of Implant Impingement

    Three-dimension videofluoroscopy is used to calculate prosthesis component relative pose, and to estimate minimum distance at the areas of risk of impingement

    12 months

  • Number of Participants with Functional Deficits at the Hip Joint as Measured by Gait Analysis

    Three-dimension kinematics and kinetics of the trunk, pelvis and lower limb joints is used during level walking and other motor tasks, as well as for the single exercises of hip joint extreme motion analyzed in videofluoroscopy, to assess thoroughly those patients with and without impingement.

    12 months

Secondary Outcomes (4)

  • Range of Motion of the operated hip versus contralateral non-operated hip

    12 months

  • Correlations between prosthetic head diameter and hip functional scores

    12 months

  • Standard Clinical Hip Scores

    pre-op, and 12 months

  • X-ray measurements

    12 months

Study Arms (3)

THA28

ACTIVE COMPARATOR

THA Corail PinnacleCoC28

Device: THA Corail PinnacleCoC28

THA36

ACTIVE COMPARATOR

THA Corail DeltaMotion36

Device: THA Corail DeltaMotion36

THA40

ACTIVE COMPARATOR

THA Corail DeltaMotion40

Device: THA Corail DeltaMotion40

Interventions

THA Corail PinnacleCoC28DEVICE

Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head

THA28
THA Corail DeltaMotion36DEVICE

Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head

THA36
THA Corail DeltaMotion40DEVICE

Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head

THA40

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with unilateral primary or secondary hip arthrosis indicated for THA;
  • Men and female, age between 35 and 55 years old;
  • BMI smaller than 30;
  • Patients able to understand the protocol and to sign the informed consent.

You may not qualify if:

  • Child-bearing female;
  • Patients with also controlateral hip arthritis;
  • Neurological patients, because of possible alteration of neuro-muscular control of the replaced hip;
  • Patients treated with joint replacement at any other lower limb articulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Links

MeSH Terms

Conditions

Osteoarthritis, HipFemoracetabular ImpingementNeoplasm Metastasis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasms

Study Officials

  • Sandro Giannini, MD, Prof

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alberto Leardini

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 28, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2016

Study Completion

December 21, 2017

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

IT(1)