Functional outcomes before and after implant removal in healed proximal humerus fractures: does implant material (PEEK vs. titanium) have an impact?

• Conditions: S42.20; M25.61

• Registration Number: DRKS00020128
• Lead Sponsor: udwig Maximilliansuniversität München

Brief Summary

There was no significant difference in ROM, CS and %CS with respect to plate materials, although lower cell adhesion is reported for the hydrophobic PEEK. However, all patients showed improved functional outcomes after IR in this pilot study.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-07-31
• Study Start: 2021-12-07
• Results First Posted: 2022-01-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Adult patients capable of giving consent with radiologically confirmed proximal humerus fracture for which surgical treatment was recommended and performed. The surgery was performed at one of the study hospitals (Department of General, Trauma and Reconstructive Surgery, LMU Munich Campus Innenstadt and Campus Großhadern) and post-traumatic shoulder stiffness.

Exclusion Criteria

-refusal to participate in the study
-Age under 18 years
-Patients not legally independent
-Dementia
-Non-command of the German language, written or spoken
-Alcoholism or drug addiction
-Beyond the index surgery (fracture care), further surgery on the affected shoulder.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survey of the range of motion of the injured shoulder by clinical examination according to the neutral zero method immediately before and after implant removal and survey of the Constant score 1 year after implant removal.

Secondary Outcome Measures

Name	Time	Method
Assessment of bony consolidation using radiographs prior to implant removal.