Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

Arthritis, Degenerative Clinical Trial

Official title:

A Consecutive Series Pilot Study Evaluating the Safety and Effectiveness of a New Hard-on-Hard Total Hip Replacement System in Patients With Non-inflammatory Arthritis With a Standard THA Metal Ion Control Group

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02154516
• Other study ID #: 2011-ODHH166
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 4, 2011
• Est. completion date: September 2023

Study information

• Verified date: April 2023
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: September 2023
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• At least 21 years old

• Skeletally mature

• Requires primary, unilateral total hip arthroplasty due to degenerative join disease

• Preoperative Harris Hip Score of less than or equal to 70

• Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk

• Given consent to participate in the study

• Able to understand the purpose of the study, his/her role, and is available for follow-up

10 year extension:

• Subject has completed the 2 year primary study

• Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form

• Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion Criteria:

• Diagnosis with high risk of Total Hip Arthroplasty (THA) failure

• Requires bilateral THA

• Requires revision of a prior hip replacement

• Active infection or sepsis

• History of local hip infection

• Known metastatic or neoplastic disease

• Conditions that may interfere with THA survival or outcomes

• Need for structural bone grafts to support the implant

• Contralateral lower extremity condition

• Has other joint replacements or plans for other joint replacements within 2 years

• Systemic steroid therapy within 3 months prior to surgery

• Life expectancy less than 2 years

• Intra-articular therapy within 6 months of enrollment

• Female of child-bearing age not using contraception

• Inadequate bone stock to support the device

• Moderate to severe renal insufficiency

• Emotional or neurological condition that would pre-empt ability or willingness to participate in the study

• BMI >40

• Above the knee amputation of the contralateral or ipsilateral leg

• Known allergies to the components of the devices

• Entered into another investigational study

• Is a prisoner

10 year extension:

• In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Degenerative
• Osteoarthritis

Intervention

Device:
• ODH Hip System

Locations

Country	Name	City	State
South Africa	Entabeni Hospital	Durban
South Africa	Zuid Afrikaans Hospital	Pretoria

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision Rate	Reoperations that led to removal or replacement of any of the acetabular or femoral components.	Up to 10 Years
Primary	Adverse Events		Up to 10 Years
Primary	Metal Ion Concentration in Whole Blood		Up to 10 years
Secondary	Harris Hip score		Up to 10 years
Secondary	Hip Disability and Osteoarthritis Outcome Scores (HOOS)		Up to 10 years
Secondary	Radiographic measures	Assessment of bone loss, radiolucencies, subsidence, and heterotopic ossification	Up to 10 years
Secondary	Health economic outcomes-Surgical blood loss	Measured in ml blood	Intra-operative
Secondary	Health economic outcomes -Length of hospital stay	Measure of days spent in hospital	Hospital admission to discharge
Secondary	Health economic outcomes-Operative time	Operative time - first incision into skin to time when last suture is applied	Intra-operative
Secondary	Health economic outcomes - Re-hospitalisations	Re-hospitalisations-number of re-admissions to hospital	Up to 10 years