Failed Conservative Radial Head Fracture Treatment, Failed Open Reduction Internal Fixation (ORIF) of a Radial Head Fracture, Fracture of the Radial Head Which is Not Amendable to an Adequate Osteosynthesis, Post-traumatic Deformity or Arthroses
Conditions
Brief summary
The purpose of this focused registry is to evaluate the clinical implications of the RHP position (relative to the articulations) regarding functional and radiographic parameters in patients treated with the RHP with a straight and curved stem.
Interventions
None listed
Sponsors
AO Clinical Investigation and Publishing Documentation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Use of a short-or long-stemmed DePuy Synthes Radial Head Prosthesis due to any of the following indications: * Fresh fracture of the radial head which is not amendable to an adequate -steosynthesis * Post-traumatic deformity or arthroses * Failed open reduction internal fixation (ORIF) * Failed conservative radial head fracture treatment * Informed consent obtained, i.e.: * Ability to understand the content of the patient information / Informed Consent Form * Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP) * Signed and dated Ethics Committee (EC) / Institutional Review Board (IRB) approved written informed consent
Exclusion criteria
* Active infection at the affected elbow * Any not medically managed severe systemic disease * Pregnancy * Prisoner * Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the functional outcome | 12 Months | Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 1 year in patients treated with a RHP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of functional outcome | 24 months | Elaborate if there is an association between the implant head and stem position (relative to the elbow articulations), functional outcomes and radiological parameters (radiolucency and arthritis) after 2 years |
| Range of motion | 12 months | To investigate range of motion of the injured limb as compared to the contralateral side |
| Adverse events | 12 months | To evaluate if the related adverse events have an effect on quality of life (EQ5D) |
Outcome results
None listed