Degenerative Arthritis of Left Glenohumeral JointNCT01954433
Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity
An observational study of Degenerative Arthritis of Left Glenohumeral Joint and Degenerative Arthritis of Right Glenohumeral Joint, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
This study compares costs and effectiveness / utility of three common orthopedic surgeries in shoulder and hand from the perspective of the Swiss health system and the clinic. The cost of health care is continuously rising, making economic considerations part of the decision process, in particular for the allocation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Arthritis of Left Glenohumeral Joint, Degenerative Arthritis of Right Glenohumeral Joint, Rotator Cuff Tear Arthropathy
- What is being tested?
- Operated TSA Patients, Operated RCR Patients and Resection interposition suspension arthroplasty (RISA)
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to 12 Oct 2020
- 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 with shoulder arthritis and/or rotator cuff tear arthropathy indicated for total shoulder prosthesis (TSA) * Patients with rotator cuff tear indicated for arthroscopic rotator cuff reconstruction (RCR) * Trapeziometacarpal osteoarthritis (TMC OA) patients indicated for resection interposition suspension arthroplasty
Who may be able to join
- Male and female patient aged 18 years and over
- Patient willing and able to give written informed consent to participate in the study including all pre-surgical and post-surgical follow-up examinations
- Patient authorizing that their health insurance be contacted to provide health-related costs for the purpose of this study
- Specific inclusion Criteria:
- TSA:
- patients diagnosed with primary or secondary glenohumeral arthritis and/or rotator cuff tear arthropathy
Show all 14Show fewer
- indicated for treatment with a total anatomic or reverse shoulder prosthesis or
- RCR:
- patients diagnosed with partial or complete rotator cuff tear
- indicated for rotator cuff reconstruction by arthroscopy
- or
- TMC OA:
- patients diagnosed with TMC OA
- indicated for surgical treatment by resection interposition suspension arthroplasty of the TMC joint
Who cannot join
- General medical contraindication to surgery
- Revision operations
- Known hypersensitivity to the materials used
- Tumour / malignoma
- Addiction or other disorders (e.g. neuromuscular, psychiatric or metabolic disorder) that would preclude accurate evaluation
- Recent history of substance abuse
Show all 12Show fewer
- Legal incompetence
- Pregnant women
- Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
- Specific exclusion Criteria:
- Other joints operated in the same session, except arthrodesis of the metacarpophalangeal (MCP) I joint
- Patients with rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity - Health Economic Investigation (Cost-effectiveness and Cost-utility Analyses) With Before and After Surgery Comparison
This study compares costs and effectiveness / utility of three common orthopedic surgeries in shoulder and hand from the perspective of the Swiss health system and the clinic.
The cost of health care is continuously rising, making economic considerations part of the decision process, in particular for the allocation of available resources. However, cost-effectiveness and cost-utility studies of interventions in the upper extremities are rare. The purpose of this study is to gain more information and to provide a basis for the decision process.
Read the detailed description
Among various recognized methods used to assess the benefits and value of medical services, cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) are taking an increasingly important role. Over recent years, economic evaluations gained interest in orthopedics, suggesting the inclusion of economic factors in addition to traditional outcome measures in the evaluation of surgical interventions.
This is a prospective mono-center observational study involving three independent patient groups (Total shoulder prosthesis for arthritis (TSA), Arthroscopic repair of rotator cuff tears (RCR), Trapeziectomy for Trapeziometacarpal Osteoarthritis (TMC OA)) of 150 patients each. Before-and-after comparisons will be made: Cost-effectiveness and cost-utility data collected post-operatively up to one (TMC OA) and two years (TSA and RCR) will be compared with those collected up to one year pre-operatively. Eligible patients unwilling to receive surgery will be followed-up for one and two years, respectively, to allow for a parallel comparison group.
- Conditions
- Degenerative Arthritis of Left Glenohumeral Joint, Degenerative Arthritis of Right Glenohumeral Joint, Rotator Cuff Tear Arthropathy, Rotator Cuff Tear, Trapeziometacarpal Osteoarthritis
- Being tested
- Operated TSA Patients, Operated RCR Patients, Resection interposition suspension arthroplasty (RISA)
- Keywords
- Cost-effectiveness analyses, Cost-utility analyses, Upper extremity, Orthopedic, Shoulder arthroplasty, Rotator cuff tear repair, Resection interposition suspension arthroplasty
- Medical subject headings
- Rotator Cuff Tear Arthropathy, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operated TSA PatientsProcedure or surgery
Total shoulder prosthesis: Anatomic or reverse total shoulder replacement is a well-standardized procedure usually performed under general anesthesia with the patient in a beach-chair position
Operated RCR PatientsProcedure or surgery
Arthroscopic rotator cuff tear reconstruction. The shoulder arthroscopy is performed according to internal and international standard procedure with patients positioned in beach-chair position under general anesthesia.
Resection interposition suspension arthroplasty (RISA)Procedure or surgery
One of five surgical techniques can be used in this study, as routinely performed by each surgeon:
- RISA with FCR-Ligament (flexor carpi radialis ligament) modified according to Epping
- RISA with FCR-Ligament modified according to Weilby
- RISA with APL-Ligament (abductor pollicis longus ligament)
- RISA with Graftjacket modified according to Weilby
- Resection arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Operated TSA Patients | Patients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis Receives: Procedure: Operated TSA Patients | |
| Non-operated TSA Patients | TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate | |
| Operated RCR Patients | Patients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy Receives: Procedure: Operated RCR Patients | |
| Non-operated RCR Patients | RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate | |
| Operated TMC OA Patients | Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint Receives: Procedure: Resection interposition suspension arthroplasty (RISA) | |
| Non-operated TMC OA Patients | TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness and cost-utility of the targeted interventions
To calculate the cost-effectiveness and cost-utility of the targeted interventions we will assess the following parameters before and after surgery:
- Health-related costs which include all direct and indirect costs before and after surgery (productivity via work status/salary and Work Productivity and Activity Impairment Questionnaire WPAI)
- Quality-Adjusted Life years (QALYs)
- Incremental Cost Effectiveness Ratio (ICER)
Measured: Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
Change in quality of life
Quality of life (utilities) derived using EuroQoL EQ-5D-5L. The primary analysis will investigate the change between immediately before and one year after surgery.
Measured: preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients
Secondary outcomes (13)
Change in quality of life in TSA- and RCR-Patients after 2 years
Quality of life (utilities) derived using EQ-5D-5L
Measured: 2 years postOP (/ after enrollment for non-operated patients)
Complications
Patient-level risk of intervention-related complications (during non-operative management, intra-operative, post-operative including events leading to revision surgeries).
Measured: From enrollment up to 1 or 2 years after surgery
Local imaging Parameters (assessed from MRT, ultrasound, radiographs)
TSA preOP:
- Status of the rotator cuff (intact / partial rupture)
- Supraspinatus muscle atrophy
- Amount of fatty infiltration in the rotator cuff muscles
- Acromiohumeral distance
- Severity of arthrosis
TSA postOP:
- Head position with respect to glenoid
- Occurrence of osteolysis and migration
- Cortical bone resorption (when a shaft is implanted)
- Status of the Tuberculum Majus
RCR preOP:
- Location and extent of the injury of the rotator cuff (partial / complete rupture)
- Amount of fatty infiltration in the rotator cuff muscles
- Extend of tendon retraction
- Signs of tendon degeneration
RCR postOP:
- Position of the anchors
- Postoperative tissue growth
TMC OA preOP:
- Stage of Osteoarthritis
- Occurrence of articular chondrocalcinosis
- Involvement of the scapho-trapezio-trapezoidal (STT) joint
- Distance between the scaphoid and the metacarpal
Measured: TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
Change of Constant (Murley) score (CS) due to surgery in TSA- and RCR-patients
The Constant (Murley) score is possibly the most commonly used tool for assessment of shoulder function. The physician asks and documents answers to Quality of life questions (pain and activity of daily living, ability to work, sleep, sports and leisure) and certain clinical parameters (active range of motion, abduction strength). The different scales will be summed and normalized to 0 = worst to 100 = best. A German version is available for clinical use.
With the CS we can assess the change and gain in functional shoulder outcome.
Measured: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
Change of range of motion due to surgery in TSA- and RCR-patients
Additional to th Constant score we assess the
- passive abduction
- passive elevation
- active and passive external rotation by 0°
- active and passive external-internal rotation by 90°
Measured: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
Change of Kapandji index and grip + key pinch strength due to surgery in TMC OA-patients
The ability to oppose the thumb of both hands will be quantified using the Kapandji index. The flexion/extension of the metacarpo-phalangeal (MCP) and inter-phalangeal (IP) joint of the affected and contralateral thumb will be measured with an electrical Goniometer (ELINK, Biometrics Ltd., Gwent, UK).
Grip strength as well as key pinch strength of both hands will be measured with the help of an electrical dynamometer and pinch gauge (ELINK, Biometrics Ltd., Gwent, UK). Three records will be taken and the mean value will be taken for analyses. The standardized testing position as recommended by the American Society of Hand Therapists will be used.
Measured: preOP, immediately preOP, 3, 6, 12 months postOP
Change of Shoulder Pain and Disability Index (SPADI) during study participation in TSA-patients
The Shoulder Pain and Disability Index (SPADI) is a short, self-administered questionnaire that provides an item scoring by a visual analogue scale (VAS) from 0 (no pain/no difficulty, i.e. best) to 11 (worst pain imaginable/so difficult required help, i.e. worst). Five items assess pain and 8 items disability of the arm (function). The unweighted means of the 5 pain and the 8 function items will be transformed into the scale from 0 (=worst) to 100 (=best) for both scales and are used to determine pain and function scores. The average of these two scores then gives the total SPADI score. A validated German version is available.
Measured: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in Oxford Shoulder Score (OSS) during study participation in RCR-patients
The OSS is a condition-specific questionnaire developed for patients with a degenerative or inflammatory state of the shoulder. It contains 12 items to be answered by the patient independently, which deal with pain (degree, time point) and possible handicaps in private and professional life. There are five categories of response for every question, corresponding to a score ranging from 0 to 4. Scores are combined to give a single score, with a range from 0 (worst outcome) to 48 (best outcome). The score can also be standardized from 0 to 100 (best) for comparison with other outcome instruments. A German version of this questionnaire is available and it is suitable for patient-based outcome after rotator cuff repair.
Measured: preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in Michigan Hand Outcomes Questionnaire (brief MHQ) during study participation in TMC OA-patients
The Michigan Hand Outcomes Questionnaire MHQ was specifically designed to measure health state domains important to patients with hand disorders. In contrast to the widely applied DASH, the MHQ seems to be more sensitive to functional changes in hand patients. Compared to the DASH and Patient Evaluation Measure, the MHQ shows the highest correlation in finger patients with grip strength and range of motion.
In this study we will use a short version of the MHQ that includes only 12 questions for patients with acute or chronic disorders of the hand. The answers are rated on a 5-point Likert scale and scores are normalized on a scale of 0 to 100. The brief MHQ demonstrated an excellent test-retest reliability.
Measured: preOP, immediately preOP, 3, 6, 12 months postOP; respectively 6 and 12 months after enrollment for non-operated patients
Change in Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) during study participation in TSA- and TMC OA-patients
The Disability of the Arm, Shoulder and Hand questionnaire (DASH) is a comprehensive self-administered questionnaire about symptoms and functioning of the entire upper extremity. The DASH enquires about the ability to perform simple and complex activities of daily living (ADL) that are commonly performed with either one or both arms. The total score is derived from the unweighted mean of 30 items, of which at least 27 have to be answered. The QuickDASH is a more efficient version of the DASH outcome measure that appears to retain its measurement properties. It contains eleven items and is similar with regard to scores and properties to the full DASH. A validated full-length German version is available that can be used in the shortened version.
Measured: TMC OA + TSA: preOP, immediately preOP, 3, 6, 12 months postOP. TSA additionally: 24 months. 6, 12 and 24 months after enrollment for non-operated patients.
Change in Subjective shoulder value (SVV) during study participation in TSA- and RCR-patients
The Subjective Shoulder Value (SSV) is based on a single question that is answered subjectively by the patients. The formulation of this question is: "What is the overall percent value of your shoulder if a completely normal shoulder represents 100%?" It is an easily administered measure of shoulder function.
Measured: RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in general health during study participation
The outcome measure "general health" is a composite of these three questions:
- patients will be asked to report their general health status on a visual analog scale from 0 (worst possible health) to 100 (best possible health) using the EQ-5D-5L instrument.
- In addition, patients will be asked to assess their current state of health related to the operated shoulder or hand at follow-up compared to the state before surgery. This so-called 'transition' question has the possible answers 'much worse', 'slightly worse', 'equal', 'slightly better', and 'much better'.
- A similar question will be asked regarding their perceived change in quality of life at follow-up compared to the state before surgery.
Measured: preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP; ; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in level of satisfaction during study participation
The outcome measure "level of satisfaction" is a composite of these two questions:
- Patients are asked to rate their level of satisfaction, with the help of a numeric rating scale (NRS: 0-10), in terms of how the outcome met up to their preoperative expectations.
- Finally, they will be asked whether - with their current knowledge of the outcome - they would again choose the operation if they found themselves in similar circumstances to those which prevailed preoperatively.
Measured: preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP. ; 6, 12 and 24 months after enrollment for non-operated patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startNov 2013
- Primary completion7 Jun 2019
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative Arthritis of Left Glenohumeral JointStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- Winterthur Institute of Health Economics (WIG), Switzerland
- Responsible party
- Sponsor
- Investigators
- Matthias P Flury, Dr. med., Principal investigator, Schulthess KlinikLaurent Audigé, DVM PhD, Study director, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954433
- Sponsor's protocol ID
- CUA-OrthopaedicsOE-CIP-v2.0
- Status last verified
- Oct 2020
- First submitted
- 17 Sep 2013
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marks M, Grobet C, Audige L. Validity, responsiveness and minimal important change of the EQ-5D-5L in patients after rotator cuff repair, shoulder arthroplasty or thumb carpometacarpal arthroplasty. Qual Life Res. 2021 Oct;30(10):2973-2982. doi: 10.1007/s11136-021-02849-7. Epub 2021 May 10.
PubMed 33973108
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs and Consequences of Three Common Orthopedic Procedures on the Upper Extremity - Health Economic Investigation (Cost-effectiveness and Cost-utility Analyses) With Before and After Surgery Comparison
- ClinicalTrials.gov ID
- NCT01954433
- Acronym / sponsor ID
- CUA-OrthopaedicsOE-CIP-v2.0
- Conditions
- Degenerative Arthritis of Left Glenohumeral Joint, Degenerative Arthritis of Right Glenohumeral Joint, Rotator Cuff Tear Arthropathy, Rotator Cuff Tear, Trapeziometacarpal Osteoarthritis
- Keywords
- Cost-effectiveness analyses, Cost-utility analyses, Upper extremity, Orthopedic, Shoulder arthroplasty, Rotator cuff tear repair, Resection interposition suspension arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- Winterthur Institute of Health Economics (WIG), Switzerland
- Study start
- Nov 2013 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 1 Oct 2013 (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.
This study compares costs and effectiveness / utility of three common orthopedic surgeries in shoulder and hand from the perspective of the Swiss health system and the clinic.
The cost of health care is continuously rising, making economic considerations part of the decision process, in particular for the allocation of available resources. However, cost-effectiveness and cost-utility studies of interventions in the upper extremities are rare. The purpose of this study is to gain more information and to provide a basis for the decision process.
Detailed description
Among various recognized methods used to assess the benefits and value of medical services, cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) are taking an increasingly important role. Over recent years, economic evaluations gained interest in orthopedics, suggesting the inclusion of economic factors in addition to traditional outcome measures in the evaluation of surgical interventions.
This is a prospective mono-center observational study involving three independent patient groups (Total shoulder prosthesis for arthritis (TSA), Arthroscopic repair of rotator cuff tears (RCR), Trapeziectomy for Trapeziometacarpal Osteoarthritis (TMC OA)) of 150 patients each. Before-and-after comparisons will be made: Cost-effectiveness and cost-utility data collected post-operatively up to one (TMC OA) and two years (TSA and RCR) will be compared with those collected up to one year pre-operatively. Eligible patients unwilling to receive surgery will be followed-up for one and two years, respectively, to allow for a parallel comparison group.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Operated TSA Patients | – | Procedure: Operated TSA PatientsPatients with glenohumeral arthritis and/or rotator cuff tear arthropathy who were operated and received a total shoulder prosthesis |
| Non-operated TSA Patients | – | –TSA-patients, indicated for treatment with a total shoulder prosthesis, who decided not to operate |
| Operated RCR Patients | – | Procedure: Operated RCR PatientsPatients with rotator cuff tear who were operated and received a rotator cuff reconstruction by arthroscopy |
| Non-operated RCR Patients | – | –RCR-patients, indicated for rotator cuff reconstruction by arthroscopy, who decided not to operate |
| Operated TMC OA Patients | – | Procedure: Resection interposition suspension arthroplasty (RISA)Patients with trapeziometacarpal (TMC) osteoarthritis who were operated and received a resection interposition suspension arthroplasty of the TMC joint |
| Non-operated TMC OA Patients | – | –TMC OA-patients, indicated for surgical treatment (resection interposition suspension arthroplasty), who decided not to operate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with shoulder arthritis and/or rotator cuff tear arthropathy indicated for total shoulder prosthesis (TSA) * Patients with rotator cuff tear indicated for arthroscopic rotator cuff reconstruction (RCR) * Trapeziometacarpal osteoarthritis (TMC OA) patients indicated for resection interposition suspension arthroplasty
Key inclusion criteria (14 listed)
- Male and female patient aged 18 years and over
- Patient willing and able to give written informed consent to participate in the study including all pre-surgical and post-surgical follow-up examinations
- Patient authorizing that their health insurance be contacted to provide health-related costs for the purpose of this study
- patients diagnosed with primary or secondary glenohumeral arthritis and/or rotator cuff tear arthropathy
- indicated for treatment with a total anatomic or reverse shoulder prosthesis or
Key exclusion criteria (12 listed)
- General medical contraindication to surgery
- Revision operations
- Known hypersensitivity to the materials used
- Tumour / malignoma
- Addiction or other disorders (e.g. neuromuscular, psychiatric or metabolic disorder) that would preclude accurate evaluation
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 |
|---|---|---|
| Operated TSA PatientsTotal shoulder prosthesis: Anatomic or reverse total shoulder replacement is a well-standardized procedure usually performed under general anesthesia with the patient in a beach-chair position | Procedure or surgery | Operated TSA Patients |
| Operated RCR PatientsArthroscopic rotator cuff tear reconstruction. The shoulder arthroscopy is performed according to internal and international standard procedure with patients positioned in beach-chair position under general anesthesia. | Procedure or surgery | Operated RCR Patients |
| Resection interposition suspension arthroplasty (RISA)One of five surgical techniques can be used in this study, as routinely performed by each surgeon: 1. RISA with FCR-Ligament (flexor carpi radialis ligament) modified according to Epping 2. RISA with FCR-Ligament modified according to Weilby 3. RISA with APL-Ligament (abductor pollicis longus ligament) 4. RISA with Graftjacket modified according to Weilby 5. Resection arthroplasty | Procedure or surgery | Operated TMC OA Patients |
Primary outcome
Cost-effectiveness and cost-utility of the targeted interventions
Time frame: Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)
To calculate the cost-effectiveness and cost-utility of the targeted interventions we will assess the following parameters before and after surgery: * Health-related costs which include all direct and indirect costs before and after surgery (productivity via work status/salary and Work Productivity and Activity Impairment Questionnaire WPAI) * Quality-Adjusted Life years (QALYs) * Incremental Cost Effectiveness Ratio (ICER)
Change in quality of life
Time frame: preOP, immediately preOP, 2 weeks, 3, 6, 12 months postOP respectively 6 and 12 months after enrollment for non-operated patients
Quality of life (utilities) derived using EuroQoL EQ-5D-5L. The primary analysis will investigate the change between immediately before and one year after surgery.
13 secondary outcomes
Change in quality of life in TSA- and RCR-Patients after 2 years
Time frame: 2 years postOP (/ after enrollment for non-operated patients)
Complications
Time frame: From enrollment up to 1 or 2 years after surgery
Local imaging Parameters (assessed from MRT, ultrasound, radiographs)
Time frame: TSA: preOP, 6 months, 1 and 2 years postOP, RCR: preOP, 6 months postOP, TMC OA: preOP
Change of Constant (Murley) score (CS) due to surgery in TSA- and RCR-patients
Time frame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
Change of range of motion due to surgery in TSA- and RCR-patients
Time frame: preOP, immediately preOP, 3, 6 months postOP. TSA additionally: 12, 24 months postOP
Change of Kapandji index and grip + key pinch strength due to surgery in TMC OA-patients
Time frame: preOP, immediately preOP, 3, 6, 12 months postOP
Change of Shoulder Pain and Disability Index (SPADI) during study participation in TSA-patients
Time frame: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in Oxford Shoulder Score (OSS) during study participation in RCR-patients
Time frame: preOP, immediately preOP, 3, 6, 12 and 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in Michigan Hand Outcomes Questionnaire (brief MHQ) during study participation in TMC OA-patients
Time frame: preOP, immediately preOP, 3, 6, 12 months postOP; respectively 6 and 12 months after enrollment for non-operated patients
Change in Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH) during study participation in TSA- and TMC OA-patients
Time frame: TMC OA + TSA: preOP, immediately preOP, 3, 6, 12 months postOP. TSA additionally: 24 months. 6, 12 and 24 months after enrollment for non-operated patients.
Change in Subjective shoulder value (SVV) during study participation in TSA- and RCR-patients
Time frame: RCR + TSA: preOP, immediately preOP, 3, 6, 12, 24 months postOP; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in general health during study participation
Time frame: preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP; ; respectively 6, 12 and 24 months after enrollment for non-operated patients
Change in level of satisfaction during study participation
Time frame: preOP, immediately preOP, 3, 6, 12 months postOP. TSA + RCR additionally: 24 months postOP. ; 6, 12 and 24 months after enrollment for non-operated patients
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 22 Oct 2020.
- Derived from this study: PubMed 33973108Marks M, Grobet C, Audige L. Validity, responsiveness and minimal important change of the EQ-5D-5L in patients after rotator cuff repair, shoulder arthroplasty or thumb carpometacarpal arthroplasty. Qual Life Res. 2021 Oct;30(10):2973-2982. doi: 10.1007/s11136-021-02849-7. Epub 2021 May 10.
- Schulthess KlinikLink provided by the sponsor.
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.
Matthias P Flury, Dr. med. principal investigator
Schulthess Klinik
Laurent Audigé, DVM PhD study director
Schulthess Klinik
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 Degenerative Arthritis of Left Glenohumeral Joint and Degenerative Arthritis of Right Glenohumeral Joint, run by Schulthess Klinik at 1 site in Switzerland.
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 14 inclusion and 12 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 22 Oct 2020. 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 Switzerland. 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?
Cost-effectiveness and cost-utility of the targeted interventions (time frame: Change from 1 year before OP at 1 (TMC OA) or 2 (RCR, TSA) years post OP (/ after enrollment for non-operated patients)). The study lists 2 primary outcomes in all. 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 NCT01954433, which also lists 1 linked publication.
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 22 Oct 2020.