Dupuytren's Disease Clinical Trial
— REMEDYOfficial title:
Multicenter, Randomized, Open-label Study Evaluating the Efficacy of Aponeurectomy Associated With Adipose Tissue Grafting Compared to Aponeurectomy Alone, on the 2-year Recurrence Rate of Dupuytren's Disease (REMEDY).
Verified date | August 2023 |
Source | Elsan |
Contact | Elias SAWAYA, MD |
Phone | (0)663420278 |
esawaya.md[@]gmail.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dupuytren's disease is a frequent hereditary disease in Northern Europe. It is a degenerative disease affecting the palmar aponeurosis of the hand. It develops a progressive contractile fibrosis which cuts the hypodermic fatty tissue, adheres to the skin and the phalanges, gradually bending the affected rays, resulting in significant functional impotence. Various medical and surgical treatments are available.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 1, 2029 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Carrier of Tubiana stage II-IV Dupuytren's disease on at least one or more rays, not previously operated - Indication of a surgery by aponeurectomy - Skin pinch of the posterior aspect of the arm of more than 1cm - Affiliation to a social security system - Patient informed of the study and having given informed consent Exclusion Criteria: - Previous surgery of any kind for Dupuytren's disease - Involvement on the thumb only - Need for a total skin graft or a pedicle flap on all the rays to be treated - Active autoimmune disease - Previous treatment with collagenase - Pregnant and breastfeeding women - Patient under legal protection - Contraindications to MRI (criteria applicable only for patients from the coordinating center, not applicable for other centers) |
Country | Name | City | State |
---|---|---|---|
France | Clinique du Diaconat | Mulhouse | |
France | Institut Aquitain de la Main | Pessac |
Lead Sponsor | Collaborator |
---|---|
Elsan |
France,
Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060. — View Citation
Coleman SR. Structural fat grafting: more than a permanent filler. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):108S-120S. doi: 10.1097/01.prs.0000234610.81672.e7. — View Citation
Engstrand C, Krevers B, Nylander G, Kvist J. Hand function and quality of life before and after fasciectomy for Dupuytren contracture. J Hand Surg Am. 2014 Jul;39(7):1333-1343.e2. doi: 10.1016/j.jhsa.2014.04.029. — View Citation
Foucher G, Medina J, Navarro R. Percutaneous needle aponeurotomy: complications and results. J Hand Surg Br. 2003 Oct;28(5):427-31. doi: 10.1016/s0266-7681(03)00013-5. — View Citation
Henry M. Dupuytren's disease: current state of the art. Hand (N Y). 2014 Mar;9(1):1-8. doi: 10.1007/s11552-013-9563-0. — View Citation
Kan HJ, Verrijp FW, Hovius SER, van Nieuwenhoven CA; Dupuytren Delphi Group; Selles RW. Recurrence of Dupuytren's contracture: A consensus-based definition. PLoS One. 2017 May 15;12(5):e0164849. doi: 10.1371/journal.pone.0164849. eCollection 2017. Erratum In: PLoS One. 2019 Apr 25;14(4):e0216313. — View Citation
Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):920-6. doi: 10.1016/j.jse.2008.12.015. Epub 2009 Mar 17. — View Citation
Mojallal A, Lequeux C, Shipkov C, Breton P, Foyatier JL, Braye F, Damour O. Improvement of skin quality after fat grafting: clinical observation and an animal study. Plast Reconstr Surg. 2009 Sep;124(3):765-774. doi: 10.1097/PRS.0b013e3181b17b8f. — View Citation
Selles RW, Zhou C, Kan HJ, Wouters RM, van Nieuwenhoven CA, Hovius SER. Percutaneous Aponeurotomy and Lipofilling versus Limited Fasciectomy for Dupuytren's Contracture: 5-Year Results from a Randomized Clinical Trial. Plast Reconstr Surg. 2018 Dec;142(6):1523-1531. doi: 10.1097/PRS.0000000000004982. — View Citation
Verhoekx JSN, Mudera V, Walbeehm ET, Hovius SER. Adipose-derived stem cells inhibit the contractile myofibroblast in Dupuytren's disease. Plast Reconstr Surg. 2013 Nov;132(5):1139-1148. doi: 10.1097/PRS.0b013e3182a3bf2b. — View Citation
Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 2-year recurrence rate of Dupuytren's disease | Recurrence being defined as follows: appearance, at 2 years post-op compared to 6 weeks post-op, of a contracture of more than 20 degrees, with palpable cord, on any treated joint. | 2 Years after intervention | |
Secondary | 3-year recurrence rate in both groups | Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 3 years post-op compared to 6 weeks post-op | 3 Years after intervention | |
Secondary | 5-year recurrence rate in both groups | Recurrence being defined as follows: Appearance of a contracture of more than 20 degrees, with palpable cord, on any treated joint, at 5 years post-op compared to 6 weeks post-op | 5 Years after intervention | |
Secondary | Comparison of the appearance of scars in both groups | Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales. | 1 Year after intervention | |
Secondary | Comparison of the appearance of scars in both groups | Use of questionnaire The Patient and Observer Scar Assessment Scale (POSAS). This questionnaire consists of 2 separate scales of 6 items each (one scale for the observer and one scale for the patient). Each item is evaluated on 10 points. The lowest score is "1" which corresponds to the appearance of normal skin. A score of 10 indicates the greatest deviation from normal skin. The total score for each of the scales is obtained by adding the score for each of the 6 items. This total score can vary between 6 and 60 for each of the scales. | 2 Years after intervention | |
Secondary | Comparison of the complication rates in both groups | Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage. | 1 Week after intervention | |
Secondary | Comparison of the complication rates in both groups | Complications are defined as Hematoma, infection, graft lysis, disunion or nerve damage. | 6 Weeks after intervention | |
Secondary | Comparison of the rate of occurrence of algodystrophy, regardless of cause | Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest. | 1 Year after intervention | |
Secondary | Comparison of the rate of occurrence of algodystrophy, regardless of cause | Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest. | 2 Years after intervention | |
Secondary | Comparison of the rate of occurrence of algodystrophy, regardless of cause | Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest. | 3 Years after intervention | |
Secondary | Comparison of the rate of occurrence of algodystrophy, regardless of cause | Collection of information on the occurrence of algodystrophy, considered as Adverse Event of Special Interest. | 5 Years after intervention | |
Secondary | Evaluation of hypodermic fat volume loss | Measurement of hypodermal fat thickness on MRI for five patients of experimental group, only include in the coordinating center.
The evolution is measured with preoperative, immediate postoperative (day of surgery) and 1-year MRI. |
1 Year after intervention | |
Secondary | Comparison of the effect on quality of life in both groups | Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function. | 6 Weeks after intervention | |
Secondary | Comparison of the effect on quality of life in both groups | Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function. | 1 Year after intervention | |
Secondary | Comparison of the effect on quality of life in both groups | Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function. | 2 Years after intervention | |
Secondary | Comparison of the effect on quality of life in both groups | Use of Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The score consists of 11 questions that assess the function of the upper limb for the gestures of daily life. The final score is between 0 and 100, with 0 corresponding to normal function, and 100 to almost no function. | 5 Years after intervention | |
Secondary | Evaluation of the safety of aponectomy surgery associated or not with adipose tissue grafting | Collection of adverse events | 6 Weeks after intervention | |
Secondary | Evaluation of the primary endpoint on the second hand operated on. | The surgery being done with or without fat according to the treatment of the 1st randomized hand (cross-over scheme).
Data collection for the second surgery only if it occurs between the 1st hand surgery and the patient's protocol discharge. |
Within five years after intervention |
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