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

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis; Osteonecrosis; Osteoarthritis, Hip; Avascular Necrosis of Hip; Post-traumatic; Arthrosis; Fracture of Hip; Dislocated Hip; Subluxation Hip
• Intervention / Treatment: Device: Patients who received the Stafit Acetabular System

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 166

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Survival	Represents the implants that survived by counting the number of implants revised.	3 years postoperatively, due to early study termination
Dislocation Rate	Assessed by counting the number of implant dislocations	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 28, 2011
• Primary Completion (ACTUAL): January 24, 2017
• Study Completion (ACTUAL): July 15, 2019

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 15, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Bone Diseases; Femoral Fractures; Hip Injuries; Osteoarthritis; Necrosis; Hip Fractures; Osteoarthritis, Hip; Osteonecrosis
• Other Study ID Numbers: 09H07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No