Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorLovisenberg Diakonale Hospital
About this trial
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
Able to read or write Norwegian
Disqualifiers
Severe osteoporosis
Osteonecrosis of the humeral head
Dementia
Poor deltoid function
Trial design
Design model
Parallel
Treatments tested in this trial
BIO-RSA
Procedure/SurgeryBony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.
RSA
Procedure/SurgeryConventional reversed shoulder arthroplasty(RSA) will be performed.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: BIO-RSAExperimental treatment 1 intervention
Group B: RSAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in WOOS index from baseline to 24 months postoperatively.
The Western Ontario Osteoarthritis of the Shoulder (WOOS) index is a patient-reported, disease-specific questionnaire for the measurement of the quality-of-life in patients with osteoarthritis. There are 19 questions divided into four domains: Physical symptoms, sports and work, lifestyle and emotions. Each question is answered on a visual analogue scale ranging from 0 to 100. The overall score ranges from 0 to 1900, with 1900 being the worst. For ease of interpretation, the scores are often converted to a percentage of the maximum score.
Time frame
Before randomization, 24 months postoperatively. Also measured 3 and 12 months postoperatively. Change after 24 months will be the primary outcome.Secondary outcomes
1
Change in EuroQol-5 from baseline to 24 months postoperatively.
The widely used EuroQol-5 (EQ-5D-5L) will be used to measure health-related quality of life. The EQ5D-5L consists of two parts: A descriptive system (Mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and the EQ-VAS that record patients self-rated health on a visual analog scale that range from 0 -100, higher levels indicate better self-rated health. The descriptive system can be converted to a single summary index number where lower levels indicate poorer health related quality of life.
Time frame
Before randomization, 3, 12 and 24 months postoperatively.2
CT scan
Assessment of bone transplant integration and fixation of the glenoid implant.
Time frame
Before randomization, 3, 12 and 24 months postoperatively.3
Change in Constant-Murley Score from baseline to 24 months postoperatively.
The Constant-Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. The test is divided into subjective and objective components. Two subjective: pain and activities of daily living (ADL) and two objective: range of motion (ROM) and strength. The subjective components can receive up to 35 points and the objective 65. Pain and ADL are answered by the patient; ROM and strength require a physical evaluation and are answered by the physiotherapist.
Time frame
Before randomization, 3, 12 and 24 months postoperatively.4
Change in range of motion from baseline to 24 months postoperatively.
The patient's active and passive range of motion (ROM) in the affected shoulder will be measured by an experienced physiotherapist with a long-legged goniometer. The directions measured will be flexion, abduction, external rotation and internal rotation, measured in degrees and/or physical landmarks.
Time frame
Before randomization, 3, 12 and 24 months postoperatively.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lovisenberg Diakonale Hospital
Lead sponsor
Haukeland University Hospital
Collaborator
Sykehuset Telemark
Collaborator
University Hospital, Akershus
Collaborator
Source ClinicalTrials.gov