Arthritis Trial Finder

Analysis of Suprapectoral and Subpectoral Biceps Tenodesis

Study Purpose

Biceps pathology typically includes pain in the anterior shoulder that is reproduced with provocative maneuvers. However, optimal treatment of patient with this diagnosis is not clear and can include tenotomy (cutting the biceps) or various forms of tenodesis (cutting then reattaching). As tenotomy can lead to cosmetic deformity and anterior humeral discomfort from spasms, many surgeons perform tenodesis. There are various techniques for tenodesis. This study will compare 2 methods: suprapectoral (doing the surgery using an incision higher in the shoulder) versus subpectoral fixation (surgery which involves making an incision lower in the shoulder). Purpose of the study is to prospectively determine whether arthroscopic suprapectoral or open subpectoral biceps tenodesis results in better function.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Scheduled to undergo biceps tenodesis - Pain at intertubercular groove - Anterior Humeral pain - Patient agrees to follow up and consent

Exclusion Criteria:

- Biceps Tenotomy - Revision biceps procedure - Prior SLAP or labral repair - Concomitant subscapularis repair - More than 1 rotator cuff repair at time of surgery - Concomitant arthroplasty - Prior infection

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02192073

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Rush University Medical Center

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Nikhil N Verma, MD
Principal Investigator Affiliation Rush Univeristy Medical Center

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Biceps Tendonitis

Contact a Trial Team

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Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

Site Contact

Barb L Ramsey, RN

312-563-2883

Nearest Location

Site Contact

Barb L Ramsey, RN

312-563-2883

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