Avenir Müller Hip Stem Post Market Surveillance Study

NCT04079127 | Completed Results

• 1 other identifier: 09H08
• Study Type: observational
• Target: 150
• 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 Avenir Müller Hip Stem.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  The Harris Hip Score is a questionnaire filled by the surgeon with the patient 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 (stair use, using public transportation, sitting, and managing shoes and socks) and gait (limp, support needed, 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 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).

  10 years

Secondary Outcomes (2)

• Confirmation of Safety Based on Complications

  up to 10 years

• Survivorship of the Implant

  10 years

Study Arms (1)

Patients suffering from severe hip pain and disability

Patients in need of a total hip arthroplasty.

Device: Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.

Interventions

Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem. DEVICE

Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.

Patients suffering from severe hip pain and disability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients able to participate in a follow-up program based upon physical examination and medical history.
• Patients or patient's legal representatives who have given written consent to take part in the study by signing the 'Patient Consent Form'.
• years minimum.
• Male and female.
• Baseline data exist (pre-, peri- and immediate postoperative)

You may not qualify if:

• Patients who are unwilling or unable to comply with the follow-up program.
• Known pregnancy.
• Patients who are skeletally immature.

Sponsors & Collaborators

• Zimmer Biomet: lead

Related Publications (1)

• Erivan R, Villatte G, Brientini JM, Kreider D, Descamps S, Boisgard S. 7-year results of primary total hip arthroplasty with the uncemented Avenir stem. Hip Int. 2019 Jul;29(4):418-423. doi: 10.1177/1120700018810211. Epub 2018 Nov 11.

  PMID: 30415580 RESULT

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

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: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: January 9, 2010
• Primary Completion: June 29, 2019
• Study Completion: August 31, 2019
• Last Updated: May 14, 2021
• Results First Posted: June 23, 2020

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share