Clinical outcome study following Total Hip Replacement using the Paragon femoral stem and Global acetabular cup prostheses

A Multi-centre, Prospective, Consecutive Series, Clinical Outcomes Study to evaluate the safety and performance of the Paragon Hip Stem and Global Acetabular Cup prostheses combination following primary Total Hip Arthroplasty in patients with non-Inflammatory Degenerative Joint Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000294651

Acronym

PGC-COP13S

Enrollment

Registered

2014-03-20

Start date

2014-06-06

Completion date

2016-03-30

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The Paragon hip stem and the Global acetabular cup non-cemented prostheses will be evaluated following primary total hip replacement surgery.

Interventions

This is a prospective study to evaluate radiological and clinical outcomes in patients who undergo primary total hip replacement surgery, using the Paragon femoral stem and Global acetabular cup. It follows the investigators standard practice for total hip arthroplasty. Surgical duration will be the same as for routine total hip replacement surgery.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

21 Years to 85 Years

Healthy volunteers

Inclusion criteria

-The individual clinically qualifies for primary total hip arthroplasty surgery. -The individual is diagnosed with a primary diagnosis of non-Inflammatory Degenerative Joint Disease. -The individual is physically and mentally willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion criteria

-The individual has an active infection within the affected hip joint. -The individual has had a previous total hip replacement or hip fusion of the affected hip joint. -The individual has a neuromuscular or neurosensory deficit which limits the ability to evaluate safety and effectiveness of the device or has a systemic disease that would affect the subject's welfare or overall outcome of the study.

Outcome results