A pilot randomized controlled trial comparing the effect of a percutaneous and lipofilling technique in patients with a secondary Dupuytren*s contracture with standard fasciectomy surgery on convalenscence, contracture correction and recurrence rate.

Dupuytren*s disease (DD) is a benign, progressive, fibroproliferative disorder
that results in the development of abnormal scar-like tissue in the palmar
fascia of the hand. Extension to the digits causes progressive digital flexion
contracture. The cause of Dupuytren*s contracture is unknown, but the
pathogenic cord is the result of myofibroblast-mediated nodules and collagen
deposits.

Dupuytren*s disease predominantly affects older men of northern European
descent. Disease prevalence varies from 2 to 42 percent, and a genetic
predilection is generally agreed upon. In literature, there is no consensus on
aetiologic factors of DD. Multiple factors (positive family history, bilateral
DD, ectopic lesions, male gender, age at onset of younger than 50 years)
contribute to the diathesis of DD. A French group published a study on the
economic and surgical burden of treating DD, indicating a considerable
financial burden to the state of treating this condition. These financial
numbers are unknown with resepect to the Netherlands. In 2006, Dupuytren*s
disease was diagnosed 7048 times in the Netherlands. In total, 5843 DD
operations were performed that year (Prismant Informatie Expertise).

The first clinical manifestations of DD are pitting and thickening of the
palmar skin and moreover, the presence of a (sometimes painful) nodule.
Classically, a nodule precedes development of a cord. Over time, which may be
months or several years, the cord gradually contracts, reeling in the MCP joint
and the PIP joint and leading to progressive digital flexion deformity.
Contracture, causing loss of hand function, is the common complaint. Over the
years many non-surgical treatments of DD (splinting, radiation, physical
therapy, ultrasonic therapy, continuous slow skeletal traction, steroid
injection, enzymatic fasciotomy) have been investigated. Only recent studies on
enzymatic fasciotomy using collagenase have shown encouraging results.
Treatment of DD is mainly surgically. Accepted options for managing diseased
skin and fascia are (1) limited fasciectomy, (2) segmental fasciectomy (3)
fasciotomy (4) dermofasciectomy. Limited fasciectomy and if necessary limited
dermofasciectomy are the most standard techniques used. In general, full
recovery of hand function takes 2-3 months. Percutaneous release of fibrotic
cord at multiple levels (on average two palmar levels and two digital levels)
is un upcoming treatment for DD. Its non-invasive character promotes fast post
operative recovery. Variable publications mention iatrogenic neurovascular and
tendon injury. Moreover, a higher recurrence rate is reported using the
percutaneous technique without additional techniques such as subdermal fat
grafting.
The clinical presentation of DD may also involve fat atrophy in the palmar
area. Autologous fat grafting is a well known procedure where fat stores of the
body are utilized to fill soft tissue contour defects in order to augment,
rejuvenate or correct. Recently, fat grafting has proven to be more than just a
filler. Clinical evidence exist for treatment of radiation damage, breast
capsular contracture, and chronic ulcerations. Furthermore, subdermal fat
grafting improves quality of the skin.In collaboration with the Miami Hand
Center (Roger K. Khouri, MD), we developed a technique in which percutaneous
release of fibrotic cords is refined in combination with subdermal fat
grafting. Subdermal dissection of the cord is performed by making multiple
superficial nicks along the entire cord. (This differs from the old
percutaneous release method, which only 2 to 3 superficial nicks in the cord
are created)The cord then chops, disintegrates and separates from the dermis.
This space is filled with fat grafts. This technique differs from standard
percutaneous release in two main major points: (1) separation and
disintegration of the cord along the entire length of the cord, and (2)
subdermal fat grafting providing padding of the palmar surface and possibly
preventing scar tissue.

A combined preliminary study of the Miami Hand Center and the department of
Plastic and Reconstructive Surgery of the Erasmus MC Rotterdam was conducted
over the last 14 months. In this period 21 patients were treated as described
above, making a total of 23 hands. We treated the complete spectrum of DD
(primary, recurrence, strong and weak diathesis, mcp and pip contractures). The
maximal follow up at this moment is 12 months. We managed to get full extension
of the joints except for residual joint contracture, with only 2 recurrence
cases. Patients were satisfied and impressed by their fast recovery. We
encountered 2 transient neuropraxias and one reflex sympathetic dystrophy
reaction in a young woman, which is not uncommon in DD treatment.

At this point a (already by the same METC committee approved) RCT for primary
Dupuytren's contracture patients is running in our Medical Centre. The reason
we want to start a RCT for secondary Dupuytren's contracture is because almost
all patients suffer from recurrent Dupuytren's disease. We want to prove that
the new minimal invasive surgery is also for this patient population a good
surgical treatment with less time to recover.

To compare treatment of secondary Dupuytren*s contracture by standard limited
(dermo)fasciectomy and by the modified percutaneous release combined with fat
grafting. We focus specifically on return to function and if applicable to
return to work (convalescence). We will also study the contracture correction,
recurrence rates and cost-effectiveness.

Interventions will be compared in a randomized controlled trail. 80 patients
with secondary Dupuytren*s contracture will be randomly assigned to the
intervention group and controlled group using a computer generation random
sequence.

Outcomes will be recorded at the first intake visit from the study, two weeks,
three weeks, six months and one-year post-operatively. Outcomes will be
measured at the Erasmus Medical Center by an structured interview, hand range
of motion measurements (TPED and boyes), sensibility (Semmes Weinstein test)
and hand swelling (hand volume) and grip. These tests will be conducted by
physical therapist of the department of Rehabilitation that are not involved in
the study and are not aware of the details of the study. There will also be a
registration about the complications due to surgery of the hand and donor site
(healing of the wound, infection, dystrophic characteristics (according to
Bruell), sensibility disorders).
There will be taken some Kodak pictures of the hand (pre- and post-
operatively).
In the interview we will ask the patient to identify on what day, following
surgery, they first returned to daily activity and work (normal hand function).
We also ask the patient to fill in the average intensity of pain on the visual
analog scale (VAS) 0-100 and questions about the hand function (DASH),
pre-operatively, and at 2 weeks, three weeks, six months and one-year
post-operatively.
We also ask the patients to fill in the CISS and the EQ-5D questionaires.

A select couple of patients from the intervention group will undergo two MRI
scans to monitor the fat. The cords that will be taken out during standard
surgery will be used for further investigation of the new technique. We will
stretch the cords and will nick the cords with the same needles that are used
during the minimal invasive surgery. This will be monitored by film/photos.

The patients are ask to fill in five questions during the one year follow-up.
1. When could you first make a full fist? (with the operated fingers)
2. When was the pain at the operated hand <=3 on the visual analog scale of 10
for the first time?
3. When were you pain free (VAS = 0 )?
4. When could you use your operated hand for daily activity for the first time?
5. When did you return to work and hobbies for the first time since the
operation?

Anti-coagulants should be stopped before the surgical procedures.

1) Limited fasciectomy and limited dermofasciectomy
- Commonly used technique the participating clinic
- Use of tourniquet
- Limited fasciectomy is performed and extended to limited dermofasciectomy
only if overlying skin is pathologically involved.
- Standard z-plasty or bruner*s incision are used. Skin flaps are raised in
plane between involved fascia and subcutaneous fat. After identification of the
neurovascular bundles, all pathologic tissue is excised from proximal to
distal. Dermofasciectomy is performed by excising involved skin and closing the
defect with full thickness skin grafts.
- When, after release of the cord, an extension defecit persists based on joint
stifness, we will perform a arthrolysis of the joint.
- Postoperative treatment consists of plaster immobilisation for 1 week. If
wound healing permits, hand therapy is started. If the wound or skin graft has
not healed sufficiently, the hand is immobilised another week. A night
extension splint is used for 3 months

2) Extensive percutaneous release in combination with subdermal fat grafting
- Technique is recently introduced in the participating clinic
- Use of tourniquet
-Subdermal dissection of the cord by multiple superficial nicks while
maintaining strong extension force (lead hand is of extreme importance to
maintain constant extension force). The cord is only superficially released by
using the bevel of a 18 gauge needle as a depth gauge. The cord is released
from proximal to distal through numerous puncture wounds. By doing this at
multiple levels along the entire cord, the cord chops and separates from the
dermis. This space is than filled with fat grafts.
- Standard liposuction is performed to harvest the fat using the Coleman
lipofilling technique.
- Fat is grafted subdermally between the divided end of the cord and between
the cord and the dermis after opening the skin withe a 14 gauge needle
proximally and distally. Per complete ray approximately 5-10 cc fat is injected
using a 2 mm blunt tip spatulated cannula.
- Postoperative extension splint for 1 week. Full use is allowed at 2 Weeks. A
night extension splint is used for 3 months.

The risks of the standard surgical procedure are well known: neurovascular
injury, CRPS symptoms, wound healing problems, stifness of the hand. The risks
of the experimental technique are similar, although we expect to encounter less
wound healing problems and decreased stifness of the hand. The risks of
standard liposuction are known and are minimal and recovery is usually fast.
There are few long-term adverse clinical effects. After a standard liposuction,
the following effects can be expected: edema and redness of the liposuction
areas for a few days, moderate contusion of the liposuction areas for a few
months. Less common complications may include: persistent edema, persistent
bleeding, hematoma, visible puncture sites. Rare complications may include:
local and systemic infection.