Clinical trial NCT04258267: Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty?
Official title: Which Factors Influence the Outcome After Anatomical and Reverse Shoulder Arthroplasty? A Prospective Longitudinal Study With Randomized Group Allocation, Towards Better Rehabilitation Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Shoulder
Keywords: "Influencing factors"
Rehabilitation
"Anatomical shoulder arthroplasty"
"Reverse shoulder arthroplasty"
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
First posted: 2020-02-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective longitudinal study with randomised group allocation, based on length of immobilization.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty.

Detailed description: The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty. Therefore, factors such as patient characteristics, indication for procedure, pre-operative shoulder pain, pre-operative shoulder function, patient expectations, psychosocial factors, lifestyle factors, length of immobilization and soft tissue integrity, are subject to study.

Secondary aims are to investigate:

1. the influences of early mobilization vs. delayed mobilization of the shoulder after shoulder arthroplasty on post-operative shoulder pain, shoulder function and quality of life.
2. the inter- and intrarater reliability of the test battery used in this project, in the shoulder arthroplasty population.
3. the inter- and intrarater reliability of the shoulder joint position sense (SJPS) test and the shoulder joint force sensation (SFS) test.
4. the routines of the orthopedic shoulder surgeons before, during and after performing a shoulder arthroplasty.
5. the routines of physiotherapists in the post-operative rehabilitation of patients with shoulder arthroplasty.
6. the associations between the Patient Reported Outcome Measures (PROMS) used in AZ Monica and the Constant Murley Score (CS), and the PROMS and the Visual Analogue Scale (VAS).

and to conduct a questionnaire - and assess its reliability - measuring the expectations of the shoulder arthroplasty patients.

In order to reach the aims of this project, a prospective longitudinal study with randomized group allocation will be carried out over 48 months with estimated starting point in January 2020 and finishing in January 2024.

Eligibility criteria: Inclusion Criteria:

* Adult men and women \>= 18 years of age
* Scheduled for primary shoulder arthroplasty

Exclusion Criteria:

* Revision surgery

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Secondary outcomes:
measure: Shoulder pain
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Shoulder function
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Active ROM in shoulder abduction, anteflexion, internal rotation and external rotation
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Shoulder muscle strength in anteflexion, internal rotation, external rotation and the lift-off movement
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Proprioception (joint position sense)
timeFrame: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Proprioception (muscle force sensation)
timeFrame: Measured pre-operatively, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Patient related outcome measures (PROMS, EQ-D)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Patient related outcome measures (PROMS, SST)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Patient related outcome measures (PROMS, NRS)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Patient related outcome measures (PROMS, DASH)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
measure: Quality of Life (SF-36)
timeFrame: Measured pre-operatively, 6 weeks post-operative, 12 weeks post-operative, 6 months postoperative, 12 months post-operative and 24 months post-operative
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: AZ Monica
state: Antwerp
Study officials:
References: