Complex Regional Pain Syndrome I of Lower LimbNCT04204200
"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"
A study testing liposomal vitamin C and standard vitamin C in people with Complex Regional Pain Syndrome I of Lower Limb, run by Centre Hospitalier de Ham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Complex Regional Pain Syndrome I of Lower Limb
- What is being tested?
- liposomal vitamin C and standard vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2014to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
About this study
Official title: Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial
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.
Read the detailed description
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.
- Being tested
- liposomal vitamin C, standard vitamin C, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal vitamin CDietary 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.
standard vitamin CDietary 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).
placeboDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Allocated to conventional vitamin C (n= 22) | Active comparator | * Received allocated conventional vitamin C (n= 22)
* Did not receive allocated conventional vitamin C (n= 0) Receives: Dietary Supplement: standard vitamin C |
| Allocated to liposomal vitamin C (n= 22) | Active comparator | * Received allocated liposomal vitamin C (n= 22)
* Did not receive allocated liposomal vitamin C (n= 0) Receives: Dietary Supplement: liposomal vitamin C |
| Allocated to placebo (n= 22) | Placebo comparator | * Received allocated intervention (n= 22)
* Did not receive allocated intervention (n= 0) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: After one-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start6 Jan 2014
- Primary completion8 Jan 2018
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Complex Regional Pain Syndrome I of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Ham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-François Cazeneuve, Centre Hospitalier de Ham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204200
- Sponsor's protocol ID
- CHHam
- Status last verified
- Jan 2020
- First submitted
- 13 Dec 2019
- Last updated
- 11 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 9775056van 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.
PubMed 9167941Matsuda 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.
PubMed 1590927Zollinger 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.
PubMed 10636366Cazeneuve 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.
PubMed 12584978Aim 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.
PubMed 28274883Harden 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.
PubMed 20493633Elhusseiny 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.
PubMed 30905082Abd-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.
PubMed 30093263de 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.
PubMed 24193325Roumen 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.
PubMed 2005162Cooney WP 3rd, Dobyns JH, Linscheid RL. Complications of Colles' fractures. J Bone Joint Surg Am. 1980;62(4):613-9.
PubMed 6155380Stanton-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.
PubMed 8577483van 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.
PubMed 9674773Oyen 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.
PubMed 8309706
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04204200
- Acronym / sponsor ID
- CHHam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Hospitalier de HamUniversity, hospital or other
- Study start
- 6 Jan 2014 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Allocated to conventional vitamin C (n= 22) | Active comparator | Dietary Supplement: standard vitamin C* Received allocated conventional vitamin C (n= 22) * Did not receive allocated conventional vitamin C (n= 0) |
| Allocated to liposomal vitamin C (n= 22) | Active comparator | Dietary Supplement: liposomal vitamin C* Received allocated liposomal vitamin C (n= 22) * Did not receive allocated liposomal vitamin C (n= 0) |
| Allocated to placebo (n= 22) | Placebo comparator | Dietary Supplement: placebo* Received allocated intervention (n= 22) * Did not receive allocated intervention (n= 0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- Pregnant, breastfeeding or considering pregnancy during the trial
- Diabetic women
- No renal lithiasis
- No deficiency Glucose-6-phosphate dehydrogenase
- Unstable medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal vitamin CThe 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. | Dietary supplement | Allocated to liposomal vitamin C (n= 22) |
| standard vitamin CThe 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). | Dietary supplement | Allocated to conventional vitamin C (n= 22) |
| placeboThe 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). | Dietary supplement | Allocated to placebo (n= 22) |
Primary outcome
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity
Time frame: After one-year of follow-up
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.
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones
Time frame: After one-year follow-up
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.
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis
Time frame: After one-year follow-up
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
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis
Time frame: After one-year follow-up
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9775056Camelot 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.
- Background: PubMed 9167941van 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.
- Background: PubMed 1590927Matsuda 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.
- Background: PubMed 10636366Zollinger 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.
- Background: PubMed 12584978Cazeneuve 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.
- Background: PubMed 28274883Aim 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.
- Background: PubMed 20493633Harden 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.
- Background: PubMed 30905082Elhusseiny 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.
- Background: PubMed 30093263Abd-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.
- Background: PubMed 24193325de 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.
- Background: PubMed 2005162Roumen 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.
- Background: PubMed 6155380Cooney WP 3rd, Dobyns JH, Linscheid RL. Complications of Colles' fractures. J Bone Joint Surg Am. 1980;62(4):613-9.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing liposomal vitamin C and standard vitamin C in people with Complex Regional Pain Syndrome I of Lower Limb, run by Centre Hospitalier de Ham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity (time frame: After one-year of follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204200, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.