Anatomical Shoulder™ Fracture PMCF Study

Zimmer Biomet

Status: Completed

Conditions: Fracture

Treatments: Procedure: Fracture Shoulder Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT02465398

06-U03

Details and patient eligibility

About

The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.

Outcome data will be collected using the following standard scoring systems:

• Constant and Murley Score

Full description

This is a multi-centre, non-comparative, prospective post-market surveillance study involving surgeons skilled in shoulder replacement surgery. Each case enrolled will receive an Anatomical Shoulder Fracture implant. All system components are CE (Conformité Européenne)-marked and commercially available. Patients will be selected according to the subject selection criteria.

All patients will undergo pe-operative, intra-operative and post-operative physical examination, radiographic evaluation according to the hospital's routine procedure and collection of quality of life metrics. Follow-up evaluations are to be conducted at 6-12 weeks (x-rays only), at 6 months and annually thereafter for a minimum period of 5 years post hospital discharge. Follow-up evaluation at 10 years post hospital discharge is optional.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age - 18 years minimum.
• Sex - male and female.
• General Health - the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history.
• Informed Consent - patient or patient's legal representative has signed a 'Patient Informed Consent form'.
• Indications - Diagnosis of trauma in the affected joint with the indication for shoulder hemiarthroplasty.

Exclusion criteria

• Patient is skeletally immature.

• Patient is pregnant.

• Patient is unwilling or unable to cooperate in a follow-up program.

• Patient is planned for a bilateral shoulder replacement.

• Patient shows one or more of the following medical conditions:

  • Pathological Fracture
  • Active Infection

• Patient requires one or more of the following medical interventions:

  • Revision surgery (non-union)
  • Inverse fracture prosthesis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Fracture device

Other group

Description:

Patient were treated with an Anatomical Shoulder Fracture device.

Treatment:

Procedure: Fracture Shoulder Arthroplasty