Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness?

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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, usually after initially good course. Cause and origin are not clear.

Vitamin C is known as an inactivator of free radicals and plays a key role in building collagen tissue. Vitamin C thus has a modulating role in inflammatory reactions. Injured and ill people have been shown to have significantly increased vitamin C needs, which underlines this role. Evidence was also found that vitamin C has a positive influence on similar diseases such as the complex regional pain syndrome (CRPS, Morbus Sudeck) on the wrist and postoperative arthrofibrosis on the knee joint.

The Investigators want to investigate whether vitamin C intake can positively influence the incidence and / or severity of postoperative shoulder stiffness after shoulder surgery.

The primary objective of this study is to investigate the effect of vitamin C on the external rotational ability of the operated shoulder in the glenohumeral joint compared to the opposite side at 12 weeks post surgery.

Secondary objectives of this study are to investigate other shoulder mobility tests, patient-reported outcomes (level of pain, ability/return to work, smoking habits), patient-reported questionnaires (Constant Score, Oxford shoulder score, DASH score) and the incidence of a frozen shoulder at 6, 12, 26, and 52 weeks post surgery.

Total duration of study: 2.5 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lindenhofgruppe AG
• Treatments: Ascorbic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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