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

NCT04079114 | Terminated Results

• 1 other identifier: 09H07
• Study Type: observational
• Target: 166
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluation of Pain and Functional Performance Determined by the Harris Hip Score

  3 years postoperatively, due to early study termination

• Confirmation of Safety Based on Complications

  3 years postoperatively, due to early study termination

Interventions

Patients who received the Stafit Acetabular System DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who are unwilling or unable to give informed consent, or to comply with the follow-up program
• Known pregnancy
• Revision hip arthroplasty

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Hip Fractures; Hip Dislocation; Osteonecrosis; Osteoarthritis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Joint Dislocations; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Early study termination leading less patients enrolled and shorter follow-up as initially planned in the study protocol.

Results Point of Contact

• Title: Emilie Rohmer, Clinical Operations Manager
• Organization: Zimmer Biomet

Emilie.Rohmer@zimmerbiomet.com

+41 58 85 48210

Study Officials

• Paola Vivoda

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: April 28, 2011
• Primary Completion: January 24, 2017
• Study Completion: July 15, 2019
• Last Updated: June 30, 2020
• Results First Posted: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share