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Completed

NCT Number: NCT01322828

Trial Comparing Single Versus Double Incision to Repair Distal Bicep Tendon Ruptures

The purpose of this study to to determine whether a single incision technique or a double incision technique is more effective in the surgical treatment of distal bicep tendon ruptures. Patients will be randomized to one of the two techniques upon consenting to the study. Prior to surgery patients will have their elbow flexion, extension, pronation, and supination strength measured. Elbow Range of motion will also be measured in each of these four movements. A number of subjective questionnaires will also be administered to the patient prior to surgery. The identical objective tests and subjective questionnaires will be completed by the patient at intervals of three months, six months, one year, and two years following their surgery. Additional information from patients clinical visits may also be collected throughout the study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hand and Upper Limb Centre, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complete rupture of the Distal Bicep tendon
  • Acute bicep tendon rupture (< 10 days since rupture)
  • 18 years of age and older

Exclusion criteria

  • Partial rupture of the Distal Bicep tendon
  • Chronic bicep tendon Ruptures (>10 days since rupture)
  • Under 18 years of age

Treatment and study plan

Distal bicep tendon reconstruction

Procedure

Randomized to either a single incision technique or a double incision technique.

Sponsors and collaborators

Lead sponsor

Hand and Upper Limb Clinic, Canada

Network

Registry information

Official study title

Randomized Control Trial Comparing Single Incision Versus Double Incision Surgery to Repair Distal Bicep Tendon Ruptures

Acronym: BRT

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2011
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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