CompletedNot Applicable

Can Secondary Total Elbow Arthroplasty After Failed Internal Fixation or Non-operative Treatment of Distal Humeral Fractures Achieve Equal Results as Primary Arthroplasty?

23 participantsStarted 2013-01-21

Plain-language summary

Total elbow arthroplasty (TEA) results in immediate pain release with good functional results after distal humerus fractures. But still open reduction and internal fixation is recommended as treatment of choise due to a lifelong loading limitiation, unknown implant survival and problematic revision surgery after TEA. The purpose of this study was to compare functional results and complication rates after primary total elbow arthroplasty (TEA) and TEA after failed reconstruction or non-operative treatment (secondary TEA) in the treatment of distal humerus fractures. We hypothesised that clinical and functional results are better for primary TEA with less complications.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Minimum age: 18 years Sex: All Inclusion Criteria: * Total elbow arthroplasty for an acute trauma with fracture due to an acute trauma * Total elbow arthroplasty due to failed reconstruction after distal humerus fracture * Total elbow arthroplasty after non-operatic treatment after distal humerus fracture Exclusion Criteria: * previous injury at the fractured elbow * neuro-muscular disease * cortisone or other immune suppressive therapy * open fracture grade II or higher according to Tscherne and Ostern

What they're measuring

Range of motion

Timeframe: minimum follow-up: 6 months

Mayo Elbow Performance Score

Timeframe: minimum follow-up: 6 months

Trial details

NCT IDNCT03302533

SponsorDiakoniekrankenhaus Friederikenstift

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-03-31

View on ClinicalTrials.gov More Elbow Fracture trials