Complex Regional Pain Syndrome I of Lower Limb Clinical Trial
Official title:
Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial
| NCT number | NCT04204200 |
| Other study ID # | CHHam |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 6, 2014 |
| Est. completion date | June 19, 2019 |
| Verified date | January 2020 |
| Source | Centre Hospitalier de Ham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Abstract:
Complex regional pain syndrome (CRPS) is a significant complication in operated
osteoarticular pathology and may adversely affect patient's quality of life. Vitamin C is an
anti-oxidant and a neuro-modulating agent. Intake of vitamin C appears to be the only
preventative factor. The objective of this study seeks to assess the effectiveness of
liposomal conditioning of vitamin-C in reducing CRPS and to show evidence that it is more
effective than taking vitamin C in its usual form.
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | June 19, 2019 |
| Est. primary completion date | January 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Female, Age > 18 years - The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later) - Consenting patient - Agrees to maintain the current level of physical activity throughout the study. - Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study. - Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study - Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol. Exclusion Criteria: - Pregnant, breastfeeding or considering pregnancy during the trial - Diabetic women - No renal lithiasis - No deficiency Glucose-6-phosphate dehydrogenase - Unstable medical conditions - Immunocompromised persons such as subjects who have undergone organ transplantation - Subjects who planned surgery during the clinical study - History of blood disorders / bleeding - Alcohol abuse (> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months - Participation in a clinical research trial within 30 days of randomization - Allergy or sensitivity to the product during the clinical study. - Persons who have a cognitive impairment and/or are unable to give an informed opinion. - Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier de Ham |
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity | We take an x-ray of the knee then we calculate of the Index of Caton and Deschamps AT / AP which must be close to 1 cm (from the upper edge to the lower edge of the patella which must be equal to the distance between the tip of the patella and anterior tibial tuberosity) to be interpreted as a transposed tuberosity. | After one-year of follow-up | |
| Primary | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones | Radiographs of the knee in monopodial support at 30° flexion (schuss) were taken. Measurement analysis of the translation of the tibia relative to the femur which must be close to 0 cm for the patient to be positive for the outcome. | After one-year follow-up | |
| Primary | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis | Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front | After one-year follow-up | |
| Primary | Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis | X-rays of the knee and Schuss profile with an internal and external decoaptation which must be close to 0 cm with pan gonogram standing from the front (x-rays of the long axes of the pelvis of the ankles with measurement of the HKA axes on the prosthesis side and on the non-side operated which must be close to 180°) to have eccentric arthritis. | After one-year follow-up |