REDAPT Revision System Study to Assess 5 Year Revision Rate & up to 10 Year Revision Rate and Safety and Effectiveness

Total Hip Arthroplasty (THA) Clinical Trial

Official title:

A Prospective, Multi-center Consecutive Series Study of Subjects Treated With the REDAPT™ Revision Femoral System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02344160
• Other study ID #: 13-4538-02
• Status: Withdrawn
• Phase: N/A
• First received: January 14, 2015
• Last updated: December 15, 2016
• Start date: December 2014
• Est. completion date: December 2028

Study information

• Verified date: December 2016
• Source: Smith & Nephew, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The objective of the study is to demonstrate non-inferiority of stem revision rate in subjects implanted with the REDAPT™ System with a revision rate of less than 9.8% at the 5 year mark assuming an observed rate of 6.5% at 5 years. Additional data will be collected as outcomes of safety and effectiveness data up to 10 years post REDAPT revision surgery.

Description:

This study is a prospective, multi-center, consecutive series study of subjects treated with REDAPT™. The safety and effectiveness of the REDAPT™ revision stem will be assessed over a maximum of 5 years with additional follow up to 10 years to assess outcomes. The objective of this study is to establish if the REDAPT™ stem revision rate is less than 9.8% at 5 years with an observed rate from literature review of 6.5% at 5 year.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject requires revision hip arthroplasty

• Subject requires subsequent revision of a joint replacement that involves the insertion, removal and/or replacement of a prosthesis or implant

• Subjects with inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant

• Treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques

• Endoprosthesis, femoral osteotomy, or Girdlestone resection

• Subject is at least 18 years of age

• Subject is skeletally mature in Investigators judgment

• Subject is willing to consent to participate in the study

• Subject is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, infection, or other conditions that would pose excessive operative risk

Exclusion Criteria:

• Known allergies to any components of the devices

• Subject is entered in another investigational drug, biologic, or device study within 30 days of active study participation

• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits

• Subject is facing current or impending incarceration

• Female subject is of child-bearing age and not using an approved method of contraception

• Mental or neurological conditions which could impair the subject's ability or willingness to comply with the study

• Physical conditions or activities which tend to place extreme loads on implants, e.g., Charcot joints, muscle deficiencies, multiple joint disabilities, etc.

• Skeletal immaturity

• Subject is severely overweight (BMI > 40)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Total Hip Arthroplasty (THA)

Intervention

Other:
• Phlebotomy
Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures

Locations

Country	Name	City	State
United States	Ran Schwarzkopf	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stem revision	the primary outcome will be assessed by the incidence of stem revision	5 years with additional follow up to 10 years	Yes
Secondary	Revision for any reason	Revision for any reason	5 years with additional follow-up to 10 years	Yes
Secondary	Radiographic Measurements	radiographic measurements to assess linear radiolucencies and subsidence to assess safety and potential change over time.	post operatively with additional follow-up to 10 years	Yes
Secondary	Hip Disability and Osteoarthritis Outcome Score (HOOS) and Euro Group Questionnaire (EQ-5D)	Subject reported outcomes will be collected and scored over time to assess change over time from baseline to 10 year post REDAPT Revision surgery	At baseline and up to 10 year follow up	No
Secondary	Harris Hip Score	Clinical evaluations to score and assess changes over time from baseline to 10 year follow up post REDAPT Revision surgery	at baseline and follow up visits up to 10 year follow up post surgically	Yes
Secondary	Number of participants with Adverse Events	Adverse events will be collected to monitor safety	Adverse events will be collected and assessed as safety out come at each study visit up to 10 years post surgery	Yes
Secondary	Metal Ion measurement in whole blood	blood will be analysed for metal ion levels at baseline and each study visit up to 10 years to assess change in serum metal ion level over time.	baseline and at each study visit up to 10 years following REDAPT REvison surgery.	Yes