PHS (CIP-20D-W-PHS-RM, v3.0)

• Research type

  Research Study

• Full title

  PERFORM™ HUMERAL SYSTEM STUDY (PHS)

• IRAS ID

  307335

• Contact name

  Puneet Monga

• Contact email

  Puneet.Monga@wwl.nhs.uk

• Sponsor organisation

  Tornier Inc. (Part of Stryker)

• Clinicaltrials.gov Identifier

  NCT05067543

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  13 years, 0 months, 1 days

• Research summary

  The PHS study is an International, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up (PMCF)study.

  The objective of this study is to collect data for the commercially available PERFORM Humeral System, non-constrained prosthesis, in both the anatomic and reversed configurations and to analyze the short, medium and long term data on safety and performance. Patient reported outcome measures (PROMs), device revision and adverse events (AEs) will be assessed annually throughout the study.

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  22/NW/0191

• Date of REC Opinion

  10 Aug 2022

• REC opinion

  Further Information Favourable Opinion