PMCF study to further substantiate the effectiveness and safety of OSTENIL® TENDON in the overall as well as indication-specific treatment of pain and restricted mobility in four different tendon disorders (patella tendon, peroneal tendon, medial epicondylus humeri and iliotibial band) in a real-life clinical setting when used according to the instructions for use.
Patient aged between 18 and 99 years
Diagnosis of symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band)
Physician's recommendation to use OSTENIL® TENDON prior to recruitment
Signed informed consent
Presence of any contra-indication or precautionary condition listed in the instructions for use, i.e.,
Ascertained hypersensitivity to any of the OSTENIL® TENDON constituents
Known pregnancy or breast feeding
Acute trauma
Patients over 18 years of age with symptomatic tendinopathy (patella tendon, peroneal tendon, medial epicondylus humeri or iliotibial band) and a recommendation for OSTENIL® TENDON treatment.
Case-only
Prospective
OSTENIL® TENDON
DeviceOSTENIL® TENDON is a CE-certified viscoelastic solution intended for peritendinous or intrasheath injection, containing 2 % sodium hyaluronate from fermentation.
Change of pain intensity 3 months after end of treatment compared to baseline (visual analogue scale)
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
Change of Upper -/ Lower Extremity Functional Scale compared to baseline
Indication specific patient questionnaire to assess effectiveness of treatment on a 5-point Likert scale (range: 0 = extreme difficulty to perform activity to 4 = no difficulty).
Change of pain intensity compared to baseline (visual analogue scale)
Evaluation of pain intensity by the patient on a 100 mm visual analogue scale. 100 mm equals the worst pain.
Change of patient-reported outcome measures (PROM)
Patient questionnaire to assess the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): pain, global and tendon-associated quality of life, daily activities, clinical global impression, mobility and satisfaction with treatment (note: not assessed at baseline)
Change of investigator-reported outcome measures
Investigator inquiry to record the perception of the physician of the following aspects (100 mm visual analogue scale; 100 mm equals a worse outcome): clinical global impression regarding the clinical severity of the tendinopathy and satisfaction with the treatment (note: not assessed at baseline)
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