Surgical safety and effectiveness in orthopedics: Swiss-wide multicenter evaluation and prediction of core outcomes in arthroscopic rotator cuff reconstruction.
In this project prospective data are collected from a representative group of specialized clinics performing arthroscopic rotator cuff repair (ARCR) to serve as reference baseline and outcome values, as well as the development of prediction models for individual patients. Ultrasound and MRI (on a subset of patients) examination will be performed at 12 months.
Study Type
OBSERVATIONAL
Enrollment
973
arthroscopic rotator cuff reconstruction and assessment with evaluation and prediction of core outcomes
Department for Shoulder and Elbow surgery Center for Musculoskeletal Surgery Campus Virchow
Berlin, Germany
Kantonsspital Baden AG,
Patient-reported change in shoulder functional outcome OSS
The Oxford Shoulder Score (OSS) is a condition-specific questionnaire developed for patients with a degenerative or inflammatory state of the shoulder. It contains twelve 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).
Time frame: at Baseline and at 6 months after surgery.
Change of shoulder stiffness
this event was defined as a postoperative restriction in passive shoulder motion diagnosed within 6 months after ARCR in at least two of the motion planes of flexion, abduction and external rotation in 0° abduction. Motion restriction is to be assessed separately for each plane
Time frame: at Baseline and at 6 months after surgery.
Local AEs (Adverse events) according to the ARCR Core Event Set (CES)
* Recurrent defect of repaired tendon(s) at 12 months: at least one repaired tendon is diagnosed with a recurrent defect by ultrasound examination.- Persistent or worsening pain * Infection * Any local event
Time frame: 24 months
Constant Murley Score (CMS)
The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The scale is from 1 to 100 with higher scores indicating better outcome.
Time frame: at 6 and 12 months
Shoulder strength (kg) in abduction at 6 and 12 months
Highest possible Weight load of the Shoulder measured by dynamometer
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Baden, Aarau, Switzerland
Kantonsspital Baselland
Binningen, Basel-Landschaft, Switzerland
Hirslanden Klinik Birshof
Münchenstein, Basel-Landschaft, Switzerland
Klinik tür Orthopädische Chirurgie und Traumatologie des Bewegungsapparates Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Zentrum für Orthopädie & Neurochirurgie In-Motion
Wallisellen, Canton of Zurich, Switzerland
Klinik Gut
St. Moritz, Kanton Graubünden, Switzerland
Hopital du Valois (RSV)
Martigny-Ville, Valais, Switzerland
University Hospital Basel
Basel, Switzerland
ARTHRO Medics AG
Basel, Switzerland
...and 10 more locations
Time frame: at 6 and 12 months
Change in Patient-reported shoulder pain on a Numeric Rating Scale (NRS)
The Numeric Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. A Higher Score means a worse outcome. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
Time frame: at 6, 12 months and 24 months
Change in Oxford Shoulder Score (OSS)
The Oxford Shoulder Score (OSS) is a validated patient-reported outcome measure (PROM). It's a shoulder-specific instrument designed to assess the outcome of all shoulder surgeries (with the exception of instability surgery). The combined total gives a minimum score of 12 and a maximum of 60. Higher scores in the OSS imply worse functionality while lower scores imply better functionality.
Time frame: at 6, 12 months and 24 months
Subjective Shoulder Value (SSV)
The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%
Time frame: at 6, 12 months and 24 months
Nonrestorative sleep (NRS) to assess Patient-reported quality of sleep
Nonrestorative sleep (NRS) is defined as the subjective experience that sleep has not been sufficiently refreshing or restorative. On a scale from 0-10, 0 is best possible outcome measure and 10 is worst possible outcome measure.
Time frame: at 6, 12 and 24 months
Return to work, change of working condition
Return to work, change of working condition is measure in a standardized questionnaire noting among others absences
Time frame: at 6, 12 and 24 months
PROMIS Depression and Anxiety Short Formto assess level of depression and anxiety
Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) scores. For PROMIS measures, higher scores equals more of the concept being measured.
Time frame: at 6, 12 and 24 months
Patient perceived shoulder functionality change, acceptability of own symptom state
Patient perceived shoulder functionality change, acceptability of own symptom state are measured with emphasis on minimally clinically important differences as stated in the cited literature with the according scored measurements
Time frame: at 6, 12 and 24 months
Quality of life (utilities and general health): EQ-5D-5L
Measured through EuroQoL version (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This tool has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 1 being the worst and 100 being the best possible outcome.
Time frame: at 12 and 24 months
Adverse event (AE) assessment: AEs reported by clinicians and patients
AEs reported by clinicians and patients (including non-local AEs within 6 months after surgery) b. Final independent surgeon and patient-rated assessment of AEs according to perceived severity and relation to treatment (according to perceived severity (rating scale from 0 \[no complication\] to 100 \[death\] \[67\]) and disturbance) c. Comprehensive Complication Index (CCI)
Time frame: 6 months
Adverse event (AE) assessment: Final independent surgeon and patient-rated assessment of AEs
Final independent surgeon and patient-rated assessment of AEs according to perceived severity and relation to treatment (according to perceived severity (rating scale from 0 \[no complication\] to 100 \[death\]) and disturbance)
Time frame: 6 months
Adverse event (AE) assessment:Comprehensive Complication Index (CCI)
Comprehensive Complication Index (CCI): The Comprehensive Complication Index is based on the complication grading by Clavien-Dindo Classification and implements every occurred complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
Time frame: 6 months
Rotator cuff and biceps tendon integrity by MRI
Postoperative integrity status of the rotator cuff classified by MRI
Time frame: at 12 months
Rotator cuff muscle fatty infiltration by MRI
Rotator cuff muscle fatty infiltration by MRI
Time frame: at 12 months
Status of repair implants e.g. anchors by MRI
Status of repair implants e.g. anchors by MRI
Time frame: at 12 months