Shoulder PainNCT01405781
Functional and Radiographic Outcomes After Shoulder Surgery
An observational study of Shoulder Pain and Osteoarthritis of Glenohumeral Joint, run by University of Utah at 2 sites in United States.
Trial summary
The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain, Osteoarthritis of Glenohumeral Joint, Rotator Cuff Tear Arthropathy
- How many people
- 1,034 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to 13 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City.
Who may be able to join
- Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City. All patients presenting complain of shoulder pain will be given the DRAM survey preoperative and then evaluated a minimum of 6 months postoperative.
Who cannot join
- All patients who have undergone total shoulder arthroplasty not utilizing a lesser tuberosity osteotomy or who have prior failed rotator cuff repair in the affected shoulder will be excluded.
- All patients who have undergone an open repair of the supraspinatus or infraspinatus rotator cuff tendons will not be eligible.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Of Utah Orthopedics Center
Salt Lake City, Utah, 84108
Veterans Administration Hospital Salt Lake City
Salt Lake City, Utah, 84108
About this study
The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.
Read the detailed description
Clinical outcome studies have been performed in the evaluation of a variety of shoulder pathologies after surgical treatment. Among these disease processes include glenohumeral osteoarthritis, rotator cuff arthropathy, acromioclavicular separations and scapulothoracic bursitis. A variety of outcomes studies have been performed on these pathologies although few have utilized several functional outcome measures. Also with respect to each of these diagnoses, several specific areas of research regarding outcomes assessment have not been investigated.
Glenohumeral osteoarthritis is one of the most common shoulder pathologies treated by orthopedic surgeons. For endstage osteoarthritis, an anatomic total shoulder arthroplasty provides excellent pain relief and functional improvement. In order to perform the replacement, the rotator cuff tendon in the front of the shoulder (subscapularis) needs to be taken down and then repaired at the completion of the case. There are three basic methods of takedown and repair: tenotomy, peel-off and lesser tuberosity osteotomy. The osteotomy has been compared clinically to tenotomy and found to provide a lower rate of subscapularis tears, higher outcome scores and universal healing evaluated using ultrasound and the PENN shoulder score.1 Gerber et al has also evaluated long-term outcomes of total shoulder arthroplasty with lesser osteotomy using the Constant score as a measure of outcomes.2 Unfortunately, many outcome studies evaluating total shoulder arthroplasty utilize the Simple Shoulder Test and the American Shoulder and Elbow Surgeons (ASES) Score which have not been evaluated. Also, osteotomy was performed only utilizing a "fleck" of bone instead of the entire lesser tuberosity. No studies to date have evaluated TSA with an osteotomy of the entire lesser tuberosity.
Reverse total shoulder arthroplasty has shown be a predictable operation for the treatment of rotator cuff arthropathy with clinical improvements in both pain and function at long term. 3,4 Dislocation has been reported between 0% to 9% after reverse total shoulder arthroplasty and has been defined as one of the top three most common complications associated with reverse TSA.3-10 There is considerable debate regarding whether the subscapularis tendon needs repair after reverse TSA. Edwards et al reported a statistically significant reduction in dislocation rates from 9% to 0% with addition of subscapularis repair.10 These results had significant bias with regards to randomization of patients. Similarly, all patients in the non-repair group were at the initial portion of his learning curve. Consequently, the risk for instability is likely lower than reported in his series.
Acromioclavicular joint separations represent one of the most common shoulder injuries accounting for approximately 9% of shoulder girdle injuries.11 Acromioclavicular injuries have been classified with increasing severity from I to VI based upon disruption of the various ligamentous and muscular supports including the acromioclavicular ligaments, coracoclavicular ligaments and deltotrapezial fascia.12 Recommended initial treatment for grade I to III injuries has been nonoperative with reasonable clinical results while initial surgical stabilization has been recommended for higher grade injuries.12-15
A variety of surgical stabilization techniques for acromioclavicular joint separations have been reported including the transfer of the coracoacromial ligament from the acromion to the end of the resected distal clavicle originally described by Weaver and Dunn in 1972.16 A modification of the Weaver-Dunn acromioclavicular reconstruction was subsequently described which included coracoclavicular stabilization with nonabsorbable suture.17 Despite this modification, residual subluxation or dislocation of the acromioclavicular joint has been identified in up to 29% of patients.17 Consequently, alternative constructs have been described including an anatomic reconstruction utilizing a tendon graft which has been shown to have superior biomechanical strength compared to a Weaver-Dunn reconstruction.18
As part of the surgical transition from the modified Weaver-Dunn reconstruction as described by Weinstein et al. to a reconstruction using a tendon graft, augmentation of the coracoclavicular suture fixation with either allograft or autograft tendon as well as performing the coracoacromial ligament transfer has been described.17,19 This differs from the anatomic reconstruction described by Mazzocca et al., as it includes both the transferred coracoacromial ligament and the hamstring graft for stabilization instead of just the graft.11 Coracoclavicular ligament reconstruction with a tendon graft has been reported as a treatment option for failed Weaver-Dunn reconstructions.20,21 Possible benefits of the combined reconstruction include improved construct strength and a vascularized ligament. Drawbacks include increased surgical dissection, increased operating room time and disruption of the coracoacromial arch. With the advances in arthroscopic techniques, acromioclavicular reconstructions utilizing a tendon graft are now being performed arthroscopically which has been described without the addition of coracoacromial ligament transfer.22 Reconstructions without coracoacromial ligament transfers may increase the ease of performing a reconstruction through smaller incisions with arthroscopic assistance. No study has evaluated the clinical effects of adding a coracoacromial ligament transfer to an acromioclavicular joint reconstruction utilizing a coracoclavicular tendon graft.
Scapulothoracic bursitis or "snapping scapula syndrome" is an under-recognized shoulder disorder where the bursal sac between the scapula and chest wall becomes irritated and inflamed. The etiology is overuse causing reactive bursa formation between the scapula and thorax. If conservative measures fail as initial attempts at management, surgical excision of the inflamed bursa with resection of the superior medial angle of the scapula can be performed. The procedure can be performed either arthroscopically or open. A two-portal or three-portal technique can be utilized if performed arthroscopically. Very limited data exists regarding outcomes of two-portal or three-portal techniques with no use of validated patient-based outcome scores.23,24
Rotator cuff tearing is the most common shoulder pathology treated by orthopedic surgeons. Healing rates after rotator cuff repair have varied in the literature from less than 5% to 100% dependent on tear size, age, repair construct and muscle quality.25,26 A variety of methods have been used to repair the tendon. A recent biomechanical study has shown that repair with triple-loaded suture anchors have improved initial biomechanical properties compared to other constructs.27 No clinical data exists on healing after repair with triple loaded anchors or how healing effects function.
- Medical subject headings
- Shoulder Pain, Rotator Cuff Tear Arthropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems.
Measured: From 6 months
Secondary outcomes (1)
To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair
Measured: from 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startMay 2011
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Other
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Tashjian, University of Utah
- Investigators
- Robert z Tashjian, MD, Principal investigator, University Of Utah Orthopedics Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405781
- Sponsor's protocol ID
- 46622
- Status last verified
- Dec 2024
- First submitted
- 27 Jul 2011
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Radiographic Outcomes After Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01405781
- Acronym / sponsor ID
- 46622
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 29 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is twofold: First, to determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair; second, to obtain functional outcomes (VAS pain, VAS satisfaction, VAS function, Simple Shoulder Test (SST) and American Shoulder and Elbow Surgeons (ASES) Score), physically examine and perform a radiographic analysis of patients at a minimum of 6 months after reverse total shoulder arthroplasty, total shoulder arthroplasty, arthroscopic scapulothoracic bursectomy, acromioclavicular joint reconstruction and arthroscopic rotator cuff repair.
Detailed description
Clinical outcome studies have been performed in the evaluation of a variety of shoulder pathologies after surgical treatment. Among these disease processes include glenohumeral osteoarthritis, rotator cuff arthropathy, acromioclavicular separations and scapulothoracic bursitis. A variety of outcomes studies have been performed on these pathologies although few have utilized several functional outcome measures. Also with respect to each of these diagnoses, several specific areas of research regarding outcomes assessment have not been investigated.
Glenohumeral osteoarthritis is one of the most common shoulder pathologies treated by orthopedic surgeons. For endstage osteoarthritis, an anatomic total shoulder arthroplasty provides excellent pain relief and functional improvement. In order to perform the replacement, the rotator cuff tendon in the front of the shoulder (subscapularis) needs to be taken down and then repaired at the completion of the case. There are three basic methods of takedown and repair: tenotomy, peel-off and lesser tuberosity osteotomy. The osteotomy has been compared clinically to tenotomy and found to provide a lower rate of subscapularis tears, higher outcome scores and universal healing evaluated using ultrasound and the PENN shoulder score.1 Gerber et al has also evaluated long-term outcomes of total shoulder arthroplasty with lesser osteotomy using the Constant score as a measure of outcomes.2 Unfortunately, many outcome studies evaluating total shoulder arthroplasty utilize the Simple Shoulder Test and the American Shoulder and Elbow Surgeons (ASES) Score which have not been evaluated. Also, osteotomy was performed only utilizing a "fleck" of bone instead of the entire lesser tuberosity. No studies to date have evaluated TSA with an osteotomy of the entire lesser tuberosity.
Reverse total shoulder arthroplasty has shown be a predictable operation for the treatment of rotator cuff arthropathy with clinical improvements in both pain and function at long term. 3,4 Dislocation has been reported between 0% to 9% after reverse total shoulder arthroplasty and has been defined as one of the top three most common complications associated with reverse TSA.3-10 There is considerable debate regarding whether the subscapularis tendon needs repair after reverse TSA. Edwards et al reported a statistically significant reduction in dislocation rates from 9% to 0% with addition of subscapularis repair.10 These results had significant bias with regards to randomization of patients. Similarly, all patients in the non-repair group were at the initial portion of his learning curve. Consequently, the risk for instability is likely lower than reported in his series.
Acromioclavicular joint separations represent one of the most common shoulder injuries accounting for approximately 9% of shoulder girdle injuries.11 Acromioclavicular injuries have been classified with increasing severity from I to VI based upon disruption of the various ligamentous and muscular supports including the acromioclavicular ligaments, coracoclavicular ligaments and deltotrapezial fascia.12 Recommended initial treatment for grade I to III injuries has been nonoperative with reasonable clinical results while initial surgical stabilization has been recommended for higher grade injuries.12-15
A variety of surgical stabilization techniques for acromioclavicular joint separations have been reported including the transfer of the coracoacromial ligament from the acromion to the end of the resected distal clavicle originally described by Weaver and Dunn in 1972.16 A modification of the Weaver-Dunn acromioclavicular reconstruction was subsequently described which included coracoclavicular stabilization with nonabsorbable suture.17 Despite this modification, residual subluxation or dislocation of the acromioclavicular joint has been identified in up to 29% of patients.17 Consequently, alternative constructs have been described including an anatomic reconstruction utilizing a tendon graft which has been shown to have superior biomechanical strength compared to a Weaver-Dunn reconstruction.18
As part of the surgical transition from the modified Weaver-Dunn reconstruction as described by Weinstein et al. to a reconstruction using a tendon graft, augmentation of the coracoclavicular suture fixation with either allograft or autograft tendon as well as performing the coracoacromial ligament transfer has been described.17,19 This differs from the anatomic reconstruction described by Mazzocca et al., as it includes both the transferred coracoacromial ligament and the hamstring graft for stabilization instead of just the graft.11 Coracoclavicular ligament reconstruction with a tendon graft has been reported as a treatment option for failed Weaver-Dunn reconstructions.20,21 Possible benefits of the combined reconstruction include improved construct strength and a vascularized ligament. Drawbacks include increased surgical dissection, increased operating room time and disruption of the coracoacromial arch. With the advances in arthroscopic techniques, acromioclavicular reconstructions utilizing a tendon graft are now being performed arthroscopically which has been described without the addition of coracoacromial ligament transfer.22 Reconstructions without coracoacromial ligament transfers may increase the ease of performing a reconstruction through smaller incisions with arthroscopic assistance. No study has evaluated the clinical effects of adding a coracoacromial ligament transfer to an acromioclavicular joint reconstruction utilizing a coracoclavicular tendon graft.
Scapulothoracic bursitis or "snapping scapula syndrome" is an under-recognized shoulder disorder where the bursal sac between the scapula and chest wall becomes irritated and inflamed. The etiology is overuse causing reactive bursa formation between the scapula and thorax. If conservative measures fail as initial attempts at management, surgical excision of the inflamed bursa with resection of the superior medial angle of the scapula can be performed. The procedure can be performed either arthroscopically or open. A two-portal or three-portal technique can be utilized if performed arthroscopically. Very limited data exists regarding outcomes of two-portal or three-portal techniques with no use of validated patient-based outcome scores.23,24
Rotator cuff tearing is the most common shoulder pathology treated by orthopedic surgeons. Healing rates after rotator cuff repair have varied in the literature from less than 5% to 100% dependent on tear size, age, repair construct and muscle quality.25,26 A variety of methods have been used to repair the tendon. A recent biomechanical study has shown that repair with triple-loaded suture anchors have improved initial biomechanical properties compared to other constructs.27 No clinical data exists on healing after repair with triple loaded anchors or how healing effects function.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City.
Key inclusion criteria (1 listed)
- Patients whose primary presenting complaint of shoulder pain and who then undergo arthroscopic rotator cuff repair performed by the principal investigator for full thickness rotator cuff tear will be eligible for inclusion. All patients who have undergone reverse total shoulder arthroplasty, total shoulder arthroplasty utilizing a lesser tuberosity osteotomy, acromioclavicular joint reconstruction, arthroscopic scapulothoracic bursectomy or arthroscopic rotator cuff repair by the PI (RZT) will also be eligible for inclusion in the study. These will include patients both at the University of Utah as well as the Veteran's Administration Hospital in Salt Lake City. All patients presenting complain of shoulder pain will be given the DRAM survey preoperative and then evaluated a minimum of 6 months postoperative.
Key exclusion criteria (2 listed)
- All patients who have undergone total shoulder arthroplasty not utilizing a lesser tuberosity osteotomy or who have prior failed rotator cuff repair in the affected shoulder will be excluded.
- All patients who have undergone an open repair of the supraspinatus or infraspinatus rotator cuff tendons will not be eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems.
Time frame: From 6 months
1 secondary outcome
To determine whether higher levels of pre-operative psychological distress predict worse outcomes after arthroscopic rotator cuff repair
Time frame: from 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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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.
Robert z Tashjian, MD principal investigator
University Of Utah Orthopedics Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Osteoarthritis of Glenohumeral Joint, run by University of Utah at 2 sites in United States.
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 1 inclusion and 2 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the outcomes after several different shoulder surgical procedures for varying shoulder problems. (time frame: From 6 months). 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 13 Jan 2025.