Efficacy of Aponeurectomy on the 2-year Recurrence Rate of Dupuytren's Disease
ConditionDupuytren's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aponeurectomy with grafting
Procedure/SurgeryThe lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system. The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions.
Aponeurectomy alone
Procedure/SurgeryThe patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: Aponeurectomy with graftingExperimental treatment 1 intervention
Group B: Aponeurectomy aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
2 Years after interventionSecondary outcomes
1
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
Time frame
3 Years after intervention2
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
Time frame
5 Years after intervention3
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.
Time frame
1 Year after intervention4
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.
Time frame
2 Years after intervention Source ClinicalTrials.gov