N/A
N=90
Functional Outcomes Following Shoulder Surgery: A Prospective Database
Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT00253864 ↗Enrolled (actual)
90
Serious AEs
2.6%
Results posted
Jun 2024
Primary outcome: Primary: Western Ontario Rotator Cuff Index — 72.9; 79.9 score on a scale (0-100)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Single row (Procedure); Double row (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario Rotator Cuff Index |
72.9; 79.9 | — |
| SECONDARY American Shoulder and Elbow Surgeons Score |
80.4; 83.0 | — |
| SECONDARY Constant Score |
77.2; 71.3 | — |
| SECONDARY Strength |
7.1; 6.9 | — |
Summary
The purpose of this prospective database is to investigate the long-term functional status of patients who have undergone various types of rotator cuff repair surgery. Patients are asked to respond to questionnaires prior to surgery and at various post-operative visits in an attempt to quantify their functional outcomes. Responses are then linked to other data such as symptoms, prior treatments, previous surgery, complications, radiographic results, etc. These data may then be used as a basis for devising guidelines for future patients and surgeons. This particular project is interested in investigating long term results of arthroscopic rotator cuff repair techniques.
Eligibility Criteria
Inclusion Criteria
- arthroscopic rotator cuff repairs that occurred between 2007-2009
- enrolled in previous study comparing single vs double-row fixation
Exclusion Criteria
- withdrew from original study
- unable or unwilling to provide written informed consent
- excluded from original study
Data sourced from ClinicalTrials.gov (NCT00253864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.