Post Market Clinical Follow-Up of the Zimmer Stafit Acetabular System

Rheumatoid Arthritis Clinical Trial

Official title:

Post Market Clinical Follow-Up Study of the Zimmer Stafit Acetabular System. A Multicenter, Prospective, Non-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04079114
• Other study ID #: 09H07
• Status: Terminated
• Start date: April 28, 2011
• Est. completion date: July 15, 2019

Study information

• Verified date: June 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a Post Market Clinical Follow up study to fulfil the post market surveillance obligations according to Medical Device Directive and European Medical Device Vigilance System (MEDDEV) 2.12-2. The data collected from this study will serve the purpose of confirming safety and performance of the Zimmer Stafit Acetabular System.

Description:

The objective of this study is to obtain implant survival and outcome data on the Stafit Acetabular System by analysis of standard scoring systems, radiographs, and adverse event records.

Data will be used to monitor pain, mobility, dislocation rate and implant survival, and to confirm the long-term safety and performance of the Stafit Acetabular System in primary total hip arthroplasty.

The study design is a multi-center, prospective, non-controlled, consecutive cohort post market clinical follow-up study, involving orthopedic surgeons skilled in total hip arthroplasty procedures and experienced with the Stafit Acetabular System.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 166
• Est. completion date: July 15, 2019
• Est. primary completion date: January 24, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females

• Patients suffering from severe hip pain and disability requiring a primary total hip arthroplasty.

• 18 years minimum

• Patients able to participate in a follow-up program based upon physical examination and medical history

• Patients who have provided written informed consent by signing the Patient Informed Consent Form.

Exclusion Criteria:

• Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program

• Known pregnancy

• Revision hip arthroplasty

Related Conditions & MeSH terms

• Avascular Necrosis of Hip
• Dislocated Hip
• Fracture of Hip
• Hip Fractures
• Joint Diseases
• Necrosis
• Osteoarthritis, Hip
• Osteonecrosis
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis
• Subluxation Hip

Intervention

Device:
• Patients who received the Stafit Acetabular System
Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survival	Represents the implants that survived by counting the number of implants revised.	3 years postoperatively, due to early study termination
Primary	Dislocation Rate	Assessed by counting the number of implant dislocations	2 years
Secondary	Evaluation of Pain and Functional Performance Determined by the Harris Hip Score	The Harris Hip Score is a questionnaire filled by the surgeon on the patients who received a hip implant. The domains covered are pain, function, absence of deformity, and range of motion. The pain domain measures pain severity and its effect on activities and need for pain medication.; The function domain consists of daily activities (stairs, public transportation, sitting, and managing shoes and socks) and gait (limp, support needed for walking, and walking distance). Deformity takes into account hip flexion, adduction, internal rotation, and extremity length discrepancy. Range of motion measures hip flexion, abduction, external and internal rotation, and adduction.; There are 10 items. The score has a minimum of 0 (worst possible score) to a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).	3 years postoperatively, due to early study termination
Secondary	Confirmation of Safety Based on Complications	Reported number of patients with adverse events related to the implant. Adverse events include: dislocations of the hip, revisions and removals of the implants	3 years postoperatively, due to early study termination