Status:
TERMINATED
Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness?
Lead Sponsor:
Lindenhofgruppe AG
Conditions:
Shoulder Stiffness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Postoperative shoulder stiffness is a common complication after shoulder surgery (incidence 10-15%). The symptoms consist primarily in a painful impairment of the mobility of the glenohumeral joint, u...
Detailed Description
Participants will be randomly allocated to the two treatment arms, vitamin C or placebo, in a 1:1 ratio Study participants in the verum group receive one capsule of Burgerstein Vitamin C retard 500mg ...
Eligibility Criteria
Inclusion
- Informed Consent as documented by signature
- 18 years or older at the time of informed consent signature
- Complication-free rotator cuff\* or shoulder arthroscopy\*\* with or without resection of the acromioclavicular joint at the orthopedics Sonnenhof. The rotator cuff operations are basically open or in mini-open technique, usually with additional tenotomy / tenodesis of the long biceps tendon.
- \* rotator cuff surgery can include tenotomy/tenodesis of long biceps tendon, intra-articular debridement with or without resection of the coracoacromial ligament and/or acromioplasty, biopsies, diagnostic arthroscopy
- \*\* Arthroscopic procedures include subacromial debridement (including partial resection of the coracoacromial ligament \& acromioplasty), diagnostic arthroscopy, tenotomy of the long biceps tendon, intra-articular debridement, resection of calcium depots for treatment of tendinitis calcarea, biopsies, stabilizations (only without postoperative immobilization)
- Sufficient knowledge of German to understand the patient information and informed consent, follow instructions by study personnel, and complete patient questionnaires \& diary
Exclusion
- Contraindications to ascorbic acid or one of the excipients, e.g. known hypersensitivity or allergy to the investigational product
- Planned single or multiple intake of vitamin supplements during the study period, which results in an additional daily intake of \> 50 mg ascorbic acid
- Known pregnancy or breast feeding
- Known or suspected non-compliance, for example drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to psychological disorders, dementia, etc.
- Participation in another interventional study within the 30 days preceding and during the present study
- Previous enrollment into the current study
- Enrollment of the investigator, his / her family members, employees and other dependent persons
- Current or previous frozen shoulder (no matter on which side)
- Pre-surgery on the affected shoulder joint (preoperative procedures include all procedures examined in this study, including all other procedures involving the glenohumeral joint and / or acromioclavicular joint. In addition, all interventions, which as a result, negatively influence the mobility of the shoulder with great likelihood up to the current time)
- Known current unstable medical problem on the not-affected shoulder joint according to the judgment of the investigator
- Taking a cortisone preparation or an immunomodulatory drug (for example methotrexate or similar)
- Alcoholism (defined as intake of more than 12g (women) or 24g (men) alcohol per day)
- Regular hemodialysis
- Known diabetes mellitus
- Known Addison's disease
- Known not correctly adjusted thyroid metabolism
- Known Parkinson's disease and similar CNS disorders (Diffuse Lewy Body Disease, Corticobasal Degeneration, Multisystem Atrophy, Progressive Supranuclear Paralysis, Essential Tumor, Huntington's Disease, Multiple Sclerosis)
- Known diseases / injuries of the peripheral nerves (Isaac's Syndrome, Stiff-Person Syndrome, Guillain-Barré Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Hereditary Neuropathies, Amyotrophic Lateral Sclerosis, Hereditary Motor Neuropathies Prone to Pressure Paralysis, Motor Neurone Diseases, Myasthenia Gravis, Spinal Muscular Atrophies, Thoracic Outlet Syndromes)
- Known infection in the shoulder joint to be operated
- Known Hyperlipidemia
- Known Uremia
- Known Thalassemia
- Known iron storage diseases
- Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Planned further operation of any kind within the next 50 days after shoulder surgery
Key Trial Info
Start Date :
April 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04472000
Start Date
April 27 2021
End Date
April 21 2024
Last Update
June 14 2024
Active Locations (2)
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1
Spital Aaberg
Aarberg, Canton of Bern, Switzerland, 3270
2
Orthopädie Sonnenhof
Bern, Switzerland