NCT02316704

Brief Summary

The primary objective of this project is to investigate, using RSA, acetabular implant migration of the OsseoTi™ G7 acetabular cup in comparison to conventional PPS coated G7 acetabular cup, and compare liner wear of thinnest available E1™ liner, allowing for the largest possible femoral head (36mm-44mm) to E1™ liner holding a 32mm femoral head in the G7 acetabular system with endpoint assessment being performed at the 2 year follow-up.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

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 Progress94%
Dec 2014Apr 2027

Study Start

First participant enrolled

December 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.2 years

First QC Date

December 6, 2014

Last Update Submit

February 8, 2021

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • RSA migration in 3 dimentions of the acetabular components as measured by Radiostereometric analysis, RSA.

    Radiostereometric analysis, RSA, is an accurate technique for measuring small relative motions from sequential sets of radiographs over time and has been used to measure polyethylene wear and implant migration. Measurements are performed in microns.

    2 year

Study Arms (4)

OsseoTi™ G7 large

ACTIVE COMPARATOR

OsseoTi™ G7 acetabular cup and an E1™ liner holding largest possible femoral head (36mm-44mm)

Device: THA with G7 PPS coted acetabular componentDevice: THA with G7 OsseoTi coted acetabular component

OsseoTi™ G7 32

ACTIVE COMPARATOR

OsseoTi™ G7 acetabular cup and an E1™ insert holding a 32mm femoral head

Device: THA with G7 PPS coted acetabular componentDevice: THA with G7 OsseoTi coted acetabular component

conventional PPS coated G7 large

ACTIVE COMPARATOR

conventional PPS coated G7 acetabular cup and an E1™ insert holding largest possible femoral head (36mm-44mm)

Device: THA with G7 PPS coted acetabular componentDevice: THA with G7 OsseoTi coted acetabular component

conventional PPS coated G7 32

ACTIVE COMPARATOR

conventional PPS coated G7 acetabular cup and an E1™ insert holding a 32mm femoral head

Device: THA with G7 PPS coted acetabular componentDevice: THA with G7 OsseoTi coted acetabular component

Interventions

THA with G7 PPS coted acetabular componentDEVICE
OsseoTi™ G7 32OsseoTi™ G7 largeconventional PPS coated G7 32conventional PPS coated G7 large
THA with G7 OsseoTi coted acetabular componentDEVICE
OsseoTi™ G7 32OsseoTi™ G7 largeconventional PPS coated G7 32conventional PPS coated G7 large

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with primary hip osteoarthritis set to receive a primary unilateral uncemented total hip arthroplasty.
  • Participants must be 18-75 years of age.
  • Participants must be able to speak and understand Danish (or depending on country where patient is enrolled).
  • Participants must be able to give informed consent and be cognitively intact.
  • Participants must be expected to be able to complete all postoperative controls.
  • Participants must not have severe comorbidities, ASA-score ≤ 3.

You may not qualify if:

  • Terminal illness.
  • Rheumatoid arthritis.
  • Previous fracture of the hip.
  • Osteonecrosis of the hip.
  • Previous infection of the hip.
  • Severe bony deformity warranting the use of non-standard implants.
  • Metastasis in the periarticular bone or proximal femur.
  • Female patients that are pregnant or planning pregnancy during follow-up period
  • If bone stock or femoral canal type, assessed on preoperative x-ray, warrants the use of cemented fixation.
  • Documented osteoporosis with patient in active medical treatment.
  • Comorbidity with altered pain perception (e.g. DM with neuropathy).
  • Participants that develop deep infection in the follow-up period are excluded from the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Sahlgrenska University Hospital, Department of Orthopedics,

Gothenburg, SW-431 80, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint 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, PhD

Study Record Dates

First Submitted

December 6, 2014

First Posted

December 15, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion (Estimated)

April 1, 2027

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

DK(1)SE(1)