Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Methods:
Three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. The first group took vitamin C in liposomal form. The second one took classical vitamin C tablets while the third one received placebo pills. Comparison was made between both groups which were identical in number and were the same average age. Results were compared and analysed at the end of one-year follow-up.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allocated to conventional vitamin C (n= 22) | Active Comparator |
|
|
| Allocated to liposomal vitamin C (n= 22) | Active Comparator |
|
|
| Allocated to placebo (n= 22) | Placebo Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal vitamin C | Dietary Supplement | The intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9775056 | Background | Camelot C, Ramare S, Lemoine J, Saillant G. [Orthopedic treatment of fractures of the lower extremity of the radius by the Judet technique. Anatomic results in function of the type of lesion: apropos of 280 cases]. Rev Chir Orthop Reparatrice Appar Mot. 1998 Apr;84(2):124-35. French. | |
| 9167941 | Background | van der Laan L, Kapitein PJ, Oyen WJ, Verhofstad AA, Hendriks T, Goris RJ. A novel animal model to evaluate oxygen derived free radical damage in soft tissue. Free Radic Res. 1997 Apr;26(4):363-72. doi: 10.3109/10715769709097816. |
Not provided
Not provided
Not provided
5 years
Information will be given after approval.
Not provided
All of 66 participants met the inclusion criteria and were randomised to treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Allocated to Conventional Vitamin C (n= 22) | Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery). |
| FG001 | Allocated to Liposomal Vitamin C (n= 22) | Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days. |
| FG002 | Allocated to Placebo (n= 22) | Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Allocated to Conventional Vitamin C (n= 22) | Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery). |
| BG001 | Allocated to Liposomal Vitamin C (n= 22) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Among 15 patients who had transposition of anterior tibial tuberosity, results shows the number of cases operated for complex regional pain syndrome (CRPS). | Posted | Number | participants | After one-year of follow-up |
|
One year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Allocated to Conventional Vitamin C (n= 22) | Participant intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery). |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jean-Francois Cazeneuve, Surgeon | Centre Hospitalier de Ham | 06 62 29 24 51 | 0033 | jfc.laon@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2019 | Dec 20, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
| standard vitamin C | Dietary Supplement | The intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery). |
|
| placebo | Dietary Supplement | The intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure). |
|
| 1590927 | Background | Matsuda T, Tanaka H, Shimazaki S, Matsuda H, Abcarian H, Reyes H, Hanumadass M. High-dose vitamin C therapy for extensive deep dermal burns. Burns. 1992 Apr;18(2):127-31. doi: 10.1016/0305-4179(92)90009-j. |
| 10636366 | Background | Zollinger PE, Tuinebreijer WE, Kreis RW, Breederveld RS. Effect of vitamin C on frequency of reflex sympathetic dystrophy in wrist fractures: a randomised trial. Lancet. 1999 Dec 11;354(9195):2025-8. doi: 10.1016/S0140-6736(99)03059-7. |
| 12584978 | Background | Cazeneuve JF, Leborgne JM, Kermad K, Hassan Y. [Vitamin C and prevention of reflex sympathetic dystrophy following surgical management of distal radius fractures]. Acta Orthop Belg. 2002 Dec;68(5):481-4. French. |
| 28274883 | Background | Aim F, Klouche S, Frison A, Bauer T, Hardy P. Efficacy of vitamin C in preventing complex regional pain syndrome after wrist fracture: A systematic review and meta-analysis. Orthop Traumatol Surg Res. 2017 May;103(3):465-470. doi: 10.1016/j.otsr.2016.12.021. Epub 2017 Mar 4. |
| 20493633 | Background | Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20. |
| 30905082 | Background | Elhusseiny KM, Abd-Elhay FA, Kamel MG, Abd El Hamid Hassan HH, El Tanany HHM, Hieu TH, Tieu TM, Low SK, Hou V, Dibas M, Huy NT. Examined and positive lymph nodes counts and lymph nodes ratio are associated with survival in major salivary gland cancer. Head Neck. 2019 Aug;41(8):2625-2635. doi: 10.1002/hed.25742. Epub 2019 Mar 23. |
| 30093263 | Background | Abd-Elhay FA, Elhusseiny KM, Kamel MG, Low SK, Sang TK, Mehyar GM, Nhat Minh LH, Hashan MR, Huy NT. Negative Lymph Node Count and Lymph Node Ratio Are Associated With Survival in Male Breast Cancer. Clin Breast Cancer. 2018 Dec;18(6):e1293-e1310. doi: 10.1016/j.clbc.2018.07.003. Epub 2018 Jul 7. |
| 24193325 | Background | de Thomasson E, Rouvreau P, Piriou P, Fitoussi F, Boury G, Judet T. [Orthopaedic treatment of colles' fractures according to judet's method]. Eur J Orthop Surg Traumatol. 1995 Dec;5(2):87-92. doi: 10.1007/BF02716246. French. |
| 2005162 | Background | Roumen RM, Hesp WL, Bruggink ED. Unstable Colles' fractures in elderly patients. A randomised trial of external fixation for redisplacement. J Bone Joint Surg Br. 1991 Mar;73(2):307-11. doi: 10.1302/0301-620X.73B2.2005162. |
| 6155380 | Background | Cooney WP 3rd, Dobyns JH, Linscheid RL. Complications of Colles' fractures. J Bone Joint Surg Am. 1980;62(4):613-9. |
| 8577483 | Background | Stanton-Hicks M, Janig W, Hassenbusch S, Haddox JD, Boas R, Wilson P. Reflex sympathetic dystrophy: changing concepts and taxonomy. Pain. 1995 Oct;63(1):127-133. doi: 10.1016/0304-3959(95)00110-E. |
| 9674773 | Background | van der Laan L, ter Laak HJ, Gabreels-Festen A, Gabreels F, Goris RJ. Complex regional pain syndrome type I (RSD): pathology of skeletal muscle and peripheral nerve. Neurology. 1998 Jul;51(1):20-5. doi: 10.1212/wnl.51.1.20. |
| 8309706 | Background | Oyen WJG, Arntz IE, Claessens RAMJ, Van der Meer JWM, Corstens FHM, Goris JAR. Reflex sympathetic dystrophy of the hand: an excessive inflammatory response? Pain. 1993 Nov;55(2):151-157. doi: 10.1016/0304-3959(93)90144-E. |
| 1452591 | Background | Tanaka H, Broaderick P, Shimazaki S, Matsuda H, Hansalia H, Hanumadass M, Reyes H, Matsuda T. How long do we need to give antioxidant therapy during resuscitation when its administration is delayed for two hours? J Burn Care Rehabil. 1992 Sep-Oct;13(5):567-72. doi: 10.1097/00004630-199209000-00010. |
| 17606778 | Background | Zollinger PE, Tuinebreijer WE, Breederveld RS, Kreis RW. Can vitamin C prevent complex regional pain syndrome in patients with wrist fractures? A randomized, controlled, multicenter dose-response study. J Bone Joint Surg Am. 2007 Jul;89(7):1424-31. doi: 10.2106/JBJS.F.01147. |
| 25187584 | Background | Ekrol I, Duckworth AD, Ralston SH, Court-Brown CM, McQueen MM. The influence of vitamin C on the outcome of distal radial fractures: a double-blind, randomized controlled trial. J Bone Joint Surg Am. 2014 Sep 3;96(17):1451-9. doi: 10.2106/JBJS.M.00268. |
| 15505459 | Background | Reuben SS. Preventing the development of complex regional pain syndrome after surgery. Anesthesiology. 2004 Nov;101(5):1215-24. doi: 10.1097/00000542-200411000-00023. No abstract available. |
| 19840748 | Background | Besse JL, Gadeyne S, Galand-Desme S, Lerat JL, Moyen B. Effect of vitamin C on prevention of complex regional pain syndrome type I in foot and ankle surgery. Foot Ankle Surg. 2009;15(4):179-82. doi: 10.1016/j.fas.2009.02.002. Epub 2009 Apr 5. |
| 22985495 | Background | Shibuya N, Humphers JM, Agarwal MR, Jupiter DC. Efficacy and safety of high-dose vitamin C on complex regional pain syndrome in extremity trauma and surgery--systematic review and meta-analysis. J Foot Ankle Surg. 2013 Jan-Feb;52(1):62-6. doi: 10.1053/j.jfas.2012.08.003. Epub 2012 Sep 15. |
| 28844420 | Background | Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24. |
Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days. |
| BG002 | Allocated to Placebo (n= 22) | Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Surgery (%) | Count of Participants | Participants |
|
| Complications (%) | Count of Participants | Participants |
|
| Scintigraphy (%) | Count of Participants | Participants |
|
| OG001 | Allocated to Liposomal Vitamin C (n= 22) | Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days. |
| OG002 | Allocated to Placebo (n= 22) | Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure). |
|
|
| 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. | Among 15 patients who had Ligamentoplasty (ACL) according to Kenneth-Jones, results shows the number of cases operated for complex regional pain syndrome (CRPS) | Posted | Number | participants | 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 | Among 18 patients who had Internal unicompartmental arthroplasty for centralized arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS) | Posted | Number | participants | 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. | Among 18 patients who had Total knee arthroplasty for eccentric arthritis, results shows the number of cases operated for complex regional pain syndrome (CRPS) | Posted | Number | participants | After one-year follow-up |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Allocated to Liposomal Vitamin C (n= 22) | Participant intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Allocated to Placebo (n= 22) | Participant intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure). | 0 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
| Male |
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Not made |
|
| CRPS = complex regional pain syndrome. |
|