Shoulder Arthropathy Associated With Other ConditionsNCT03430167
Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
A study testing home therapy and formal therapy in people with Shoulder Arthropathy Associated With Other Conditions, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial. Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Shoulder Arthropathy Associated With Other Conditions
- What is being tested?
- home therapy and formal therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2018to 12 Jan 2023
- Phase
- Interventional
- 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 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
- A pre-operative plan for RTSA
- Age >60
Who cannot join
- Active infection
- Incompetent deltoid muscle
- Unwillingness or inability to participate in a home exercise program
- Medically unfit for operative intervention
- Revision RTSA
- RTSA for glenohumeral osteoarthritis or proximal humerus fracture
- Unwillingness to participate in the study
- Inability to read or comprehend written instructions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah - Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.
Read the detailed description
All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function.
Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively.
Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty.
Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.
- Being tested
- home therapy, formal therapy
- Keywords
- Reverse Total Shoulder Arthroplasty, post operative physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home therapyOther
Patients will be given a set of instructions for completing home therapy for range of motion and strengthening
formal therapyOther
Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Group I - Formal Therapy | Other | Supervised physical therapy will be ordered 2 times/week initially for 6 weeks and then tailored to a minimum of 1 visit/week based upon the individual progress of each patient. Home exercises will be provided to the patient by the therapist to be performed daily. Supervised physical therapy will be discontinued once the patient demonstrates independence with the final phase of rehabilitation, which represents the graduated strengthening program. Receives: Other: formal therapy |
| Group II - Home Therapy | Other | In the study group all patients will be instructed in a standardized fashion regarding a home exercise program. This program will involve a standardized a set of five exercises. These exercises will be reviewed with patients in clinic in a standardized fashion and patients will be provided with an instructive hand-out. Receives: Other: home therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion Outcomes
Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Measured: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Secondary outcomes (3)
Clinical Outcome Scores - Quality of Life
Compare change in The Western Ontario Osteoarthritis Score (WOOS) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
The WOOS includes 19 items (0-100 visual analog scale) which assess 1. pain and physical symptoms 2. sports, recreation, and work 3. lifestyle function, and 4. emotional function. A higher score represents a worse outcome.
Measured: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Clinical Outcome Scores - Functional
Compare change in American Shoulder and Elbow Surgeons Score (ASES) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
The ASES includes 1 pain item (0-100 visual analog scale) and 10 items which assess functional status (0=Unable to do, 1=Very difficult to do, 2=Somewhat difficult, 3=Not difficult). A higher score represents a better outcome.
Measured: Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively
Clinical Outcome Scores - Pain
Compare change in Visual Analogue Pain Score (0-100) after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
Measured: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start29 Jan 2018
- Primary completion12 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Shoulder Arthropathy Associated With Other ConditionsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Chamberlain, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430167
- Sponsor's protocol ID
- 201703024
- Status last verified
- Mar 2023
- First submitted
- 23 Jan 2018
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.
PubMed 22258770Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015 Jan;24(1):91-7. doi: 10.1016/j.jse.2014.08.026. Epub 2014 Oct 29.
PubMed 25440519Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012 Nov;21(11):1464-9. doi: 10.1016/j.jse.2011.11.012. Epub 2012 Feb 22.
PubMed 22365817Young SW, Zhu M, Walker CG, Poon PC. Comparison of functional outcomes of reverse shoulder arthroplasty with those of hemiarthroplasty in the treatment of cuff-tear arthropathy: a matched-pair analysis. J Bone Joint Surg Am. 2013 May 15;95(10):910-5. doi: 10.2106/JBJS.L.00302.
PubMed 23677358Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006 Aug;88(8):1742-7. doi: 10.2106/JBJS.E.00851.
PubMed 16882896Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010 Nov 3;92(15):2544-56. doi: 10.2106/JBJS.I.00912.
PubMed 21048173Steen BM, Cabezas AF, Santoni BG, Hussey MM, Cusick MC, Kumar AG, Frankle MA. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015 Sep;24(9):1433-41. doi: 10.1016/j.jse.2015.01.005. Epub 2015 Mar 11.
PubMed 25769903Wall B, Nove-Josserand L, O'Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007 Jul;89(7):1476-85. doi: 10.2106/JBJS.F.00666.
PubMed 17606786Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011 Sep;469(9):2469-75. doi: 10.1007/s11999-011-1833-y.
PubMed 21384212Kiet TK, Feeley BT, Naimark M, Gajiu T, Hall SL, Chung TT, Ma CB. Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Feb;24(2):179-85. doi: 10.1016/j.jse.2014.06.039. Epub 2014 Sep 9.
PubMed 25213827Cazeneuve JF, Cristofari DJ. The reverse shoulder prosthesis in the treatment of fractures of the proximal humerus in the elderly. J Bone Joint Surg Br. 2010 Apr;92(4):535-9. doi: 10.1302/0301-620X.92B4.22450.
PubMed 20357330Levy JC, Badman B. Reverse shoulder prosthesis for acute four-part fracture: tuberosity fixation using a horseshoe graft. J Orthop Trauma. 2011 May;25(5):318-24. doi: 10.1097/BOT.0b013e3181f22088.
PubMed 21464740Frankle M, Siegal S, Pupello D, Saleem A, Mighell M, Vasey M. The Reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. A minimum two-year follow-up study of sixty patients. J Bone Joint Surg Am. 2005 Aug;87(8):1697-705. doi: 10.2106/JBJS.D.02813.
PubMed 16085607Chalmers PN, Slikker W 3rd, Mall NA, Gupta AK, Rahman Z, Enriquez D, Nicholson GP. Reverse total shoulder arthroplasty for acute proximal humeral fracture: comparison to open reduction-internal fixation and hemiarthroplasty. J Shoulder Elbow Surg. 2014 Feb;23(2):197-204. doi: 10.1016/j.jse.2013.07.044. Epub 2013 Sep 27.
PubMed 24076000Cvetanovich GL, Chalmers PN, Streit JJ, Romeo AA, Nicholson GP. Patients Undergoing Total Shoulder Arthroplasty on the Dominant Extremity Attain Greater Postoperative ROM. Clin Orthop Relat Res. 2015 Oct;473(10):3221-5. doi: 10.1007/s11999-015-4400-0. Epub 2015 Jun 12.
PubMed 26066068
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Physiotherapy Versus a Home Exercise Program After Reverse Total Shoulder Arthroplasty: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03430167
- Acronym / sponsor ID
- 201703024
- Keywords
- Reverse Total Shoulder Arthroplasty, post operative physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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 purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear arthropathy/massive cuff tear through a single-center, assessor-blinded, randomized clinical trial.
Detailed description
All patients who are evaluated by one of three Shoulder/Elbow Fellowship-trained surgeons at Washington University Department of Orthopedic Surgery and who meet the inclusion criteria will be offered enrollment in the study. Following consent the participant will be asked to undergo an exam of the shoulder and complete questionnaires related to shoulder pain and function.
Demographic information, health history related to the affected shoulder, and co-morbidity data will also be collected preoperatively.
Patients will be randomized to either a simple, standardized home exercise program or a supervised physiotherapy program administered by a physical therapist after undergoing a standardized operative protocol for reverse total shoulder arthroplasty.
Post-operative range of motion will be measured in a blinded fashion at 6 weeks, 3 months, 6 months, and 12 months. A blinded observer will simultaneously measure validated functional outcomes scores including the Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons Score and Visual Analogue Score for pain pre-operatively and at 6 weeks, 3 months, 6 months, and 12 months post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Formal Therapy | Other | Other: formal therapySupervised physical therapy will be ordered 2 times/week initially for 6 weeks and then tailored to a minimum of 1 visit/week based upon the individual progress of each patient. Home exercises will be provided to the patient by the therapist to be performed daily. Supervised physical therapy will be discontinued once the patient demonstrates independence with the final phase of rehabilitation, which represents the graduated strengthening program. |
| Group II - Home Therapy | Other | Other: home therapyIn the study group all patients will be instructed in a standardized fashion regarding a home exercise program. This program will involve a standardized a set of five exercises. These exercises will be reviewed with patients in clinic in a standardized fashion and patients will be provided with an instructive hand-out. |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary RTSA for the diagnosis of rotator cuff tear arthropathy (RCTA) or irreparable rotator cuff tear.
- A pre-operative plan for RTSA
- Age >60
Key exclusion criteria (8 listed)
- Active infection
- Incompetent deltoid muscle
- Unwillingness or inability to participate in a home exercise program
- Medically unfit for operative intervention
- Revision RTSA
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 |
|---|---|---|
| home therapyPatients will be given a set of instructions for completing home therapy for range of motion and strengthening | Other | Group II - Home Therapy |
| formal therapyPatients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises | Other | Group I - Formal Therapy |
Primary outcome
Range of Motion Outcomes
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Compare change in shoulder range of motion after supervised physiotherapy versus a structured home exercise program after Reverse Total Shoulder Arthroplasty.
3 secondary outcomes
Clinical Outcome Scores - Quality of Life
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
Clinical Outcome Scores - Functional
Time frame: Baseline and at 6 weeks, 3 months, 2 months and 24 months post-operatively
Clinical Outcome Scores - Pain
Time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively
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 23 Mar 2023.
- Background: PubMed 22258770Kim SH, Wise BL, Zhang Y, Szabo RM. Increasing incidence of shoulder arthroplasty in the United States. J Bone Joint Surg Am. 2011 Dec 21;93(24):2249-54. doi: 10.2106/JBJS.J.01994.
- Background: PubMed 25440519Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. National utilization of reverse total shoulder arthroplasty in the United States. J Shoulder Elbow Surg. 2015 Jan;24(1):91-7. doi: 10.1016/j.jse.2014.08.026. Epub 2014 Oct 29.
- Background: PubMed 22365817Lawrence TM, Ahmadi S, Sanchez-Sotelo J, Sperling JW, Cofield RH. Patient reported activities after reverse shoulder arthroplasty: part II. J Shoulder Elbow Surg. 2012 Nov;21(11):1464-9. doi: 10.1016/j.jse.2011.11.012. Epub 2012 Feb 22.
- Background: PubMed 23677358Young SW, Zhu M, Walker CG, Poon PC. Comparison of functional outcomes of reverse shoulder arthroplasty with those of hemiarthroplasty in the treatment of cuff-tear arthropathy: a matched-pair analysis. J Bone Joint Surg Am. 2013 May 15;95(10):910-5. doi: 10.2106/JBJS.L.00302.
- Background: PubMed 16882896Guery J, Favard L, Sirveaux F, Oudet D, Mole D, Walch G. Reverse total shoulder arthroplasty. Survivorship analysis of eighty replacements followed for five to ten years. J Bone Joint Surg Am. 2006 Aug;88(8):1742-7. doi: 10.2106/JBJS.E.00851.
- Background: PubMed 21048173Mulieri P, Dunning P, Klein S, Pupello D, Frankle M. Reverse shoulder arthroplasty for the treatment of irreparable rotator cuff tear without glenohumeral arthritis. J Bone Joint Surg Am. 2010 Nov 3;92(15):2544-56. doi: 10.2106/JBJS.I.00912.
- Background: PubMed 25769903Steen BM, Cabezas AF, Santoni BG, Hussey MM, Cusick MC, Kumar AG, Frankle MA. Outcome and value of reverse shoulder arthroplasty for treatment of glenohumeral osteoarthritis: a matched cohort. J Shoulder Elbow Surg. 2015 Sep;24(9):1433-41. doi: 10.1016/j.jse.2015.01.005. Epub 2015 Mar 11.
- Background: PubMed 17606786Wall B, Nove-Josserand L, O'Connor DP, Edwards TB, Walch G. Reverse total shoulder arthroplasty: a review of results according to etiology. J Bone Joint Surg Am. 2007 Jul;89(7):1476-85. doi: 10.2106/JBJS.F.00666.
- Background: PubMed 21384212Favard L, Levigne C, Nerot C, Gerber C, De Wilde L, Mole D. Reverse prostheses in arthropathies with cuff tear: are survivorship and function maintained over time? Clin Orthop Relat Res. 2011 Sep;469(9):2469-75. doi: 10.1007/s11999-011-1833-y.
- Background: PubMed 25213827Kiet TK, Feeley BT, Naimark M, Gajiu T, Hall SL, Chung TT, Ma CB. Outcomes after shoulder replacement: comparison between reverse and anatomic total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Feb;24(2):179-85. doi: 10.1016/j.jse.2014.06.039. Epub 2014 Sep 9.
- Background: PubMed 20357330Cazeneuve JF, Cristofari DJ. The reverse shoulder prosthesis in the treatment of fractures of the proximal humerus in the elderly. J Bone Joint Surg Br. 2010 Apr;92(4):535-9. doi: 10.1302/0301-620X.92B4.22450.
- Background: PubMed 21464740Levy JC, Badman B. Reverse shoulder prosthesis for acute four-part fracture: tuberosity fixation using a horseshoe graft. J Orthop Trauma. 2011 May;25(5):318-24. doi: 10.1097/BOT.0b013e3181f22088.
- Individual participant dataSharing planned: No
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.
Aaron Chamberlain, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home therapy and formal therapy in people with Shoulder Arthropathy Associated With Other Conditions, run by Washington University School of Medicine at 1 site 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 3 inclusion and 8 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 23 Mar 2023. 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 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?
Range of Motion Outcomes (time frame: Baseline and at 6 weeks, 3 months, 12 months and 24 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430167, which also lists 23 linked publications.
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 23 Mar 2023.