Rotator Cuff TearNCT00253864
Functional Outcomes Following Shoulder Surgery: A Prospective Database
An observational study of Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Single row and Double row
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2004to Jan 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who underwent an arthroscopic rotator cuff surgery between 2007-2009.
Who may be able to join
- arthroscopic rotator cuff repairs that occurred between 2007-2009
- enrolled in previous study comparing single vs double-row fixation
Who cannot join
- withdrew from original study
- unable or unwilling to provide written informed consent
- excluded from original study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Outcome Following Shoulder Surgery: A Prospective Database
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.
Read the detailed description
The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results.
For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.
- Conditions
- Rotator Cuff Tear
- Being tested
- Single row, Double row
- Keywords
- shoulder surgery, prospective database, long term outcome
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single rowProcedure or surgery
Fixation type in arthroscopic rotator cuff repair.
Double rowProcedure or surgery
Fixation type in arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic rotator cuff repair | Participants who underwent an arthroscopic rotator cuff repair between 2007-2009. Receives: Procedure: Single row; Procedure: Double row |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario Rotator Cuff Index
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Measured: 10 year post operative
Secondary outcomes (3)
American Shoulder and Elbow Surgeons Score
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Measured: 10 year post operative
Constant Score
The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).
Measured: 10 year post operative
Strength
Strength will be measured using a handheld dynamometer in the abduction position which records kilograms of force. The higher the kilogram of force indicates a better result.
Measured: 10 year post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2020
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253864
- Sponsor's protocol ID
- 2003658-01H
- Status last verified
- Jan 2024
- First submitted
- 10 Nov 2005
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome Following Shoulder Surgery: A Prospective Database
- ClinicalTrials.gov ID
- NCT00253864
- Acronym / sponsor ID
- 2003658-01H
- Conditions
- Rotator Cuff Tear
- Keywords
- shoulder surgery, prospective database, long term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Nov 2004 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of the prospective database is to initiate data collection for a group of patients undergoing surgery of the shoulder. Long-term data collection will include information on the functional status of the patients' shoulder as well as quality of life information and radiographic results.
For the purposes of this study, we are interested in the long-term outcomes of participants who underwent a double row versus single row fixation in arthroscopic rotator cuff repair procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic rotator cuff repair | – | Procedure: Single row, Procedure: Double rowParticipants who underwent an arthroscopic rotator cuff repair between 2007-2009. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who underwent an arthroscopic rotator cuff surgery between 2007-2009.
Key inclusion criteria (2 listed)
- arthroscopic rotator cuff repairs that occurred between 2007-2009
- enrolled in previous study comparing single vs double-row fixation
Key exclusion criteria (3 listed)
- withdrew from original study
- unable or unwilling to provide written informed consent
- excluded from original study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single rowFixation type in arthroscopic rotator cuff repair. | Procedure or surgery | Arthroscopic rotator cuff repair |
| Double rowFixation type in arthroscopic rotator cuff repair. | Procedure or surgery | Arthroscopic rotator cuff repair |
Primary outcome
Western Ontario Rotator Cuff Index
Time frame: 10 year post operative
The Western Ontario Rotator Cuff Index (WORC) is a disease specific evaluation, proven to be an accurate and valid assessment of function after. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
3 secondary outcomes
American Shoulder and Elbow Surgeons Score
Time frame: 10 year post operative
Constant Score
Time frame: 10 year post operative
Strength
Time frame: 10 year post operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lapner, MD principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tear, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Rotator Cuff Index (time frame: 10 year post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.