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
Not provided
Not provided
The purpose of this study is to investigate whether percutaneous needle fasciotomy is as effective for treating Dupuytrens contracture as Xiapex. Immidiate treatment effect is to be investigated, as iskontracture size after 5 years. Contracture size after one and three years, and subjective hand function is also to be investigated.
Prospective randomized study between Percutanous Needle Fasciotomy and Xiapex for Dupuytrens contracture.
A total of 50 patiens are to be randomized to eighter percutaneous needle fasciotomy or Xiapex treatment.
The patients randomized to xiapex treatment are treated as described in the product manual. Extentin treatment after one day.
The patients randomized to percutaneous needle fasciotomy are treated with the cutting teqnique: A littel quaddle local anestesia (xylocaine with adrenaline) is to be injected subcutant over the cord. After thet we use a 19G needle to cut the cord sufficient number sites to extend the finger.
The patients will be follwed up at 3 weeks, 3 months, 1 year, 3 years and 5 years. Investigators record contracture size, quicq-DASH, pain (VAS) and hand disability (VAS) pretreatment and at all controlls. At 3 weeks investigators register procedure complain. Side effects and complications, and advere effects are also to be investigated.
Our hypothesis is that it is no difference between the two methods in regard of contracture size after five years.
Inclution criteria: Symptomatic primary Dupuytrens contracture with palpable cord in one to three fingers, involving MCP, and total contracture size is over 30 degrees. Patient age over 18 years.
Exclution criteria:
Previously treated Dupuytrens contracture in the same hand more than tree affected fingers we will not include thumbs Other symptomatic injury or disease influencingf hand function ASA>3 Expected lifetime less than five years tetracycline treatment within two weeks pregnancy nursing allergy to clostridium histolyticum concmittent other clinical trial
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| xiapex | Active Comparator | 1: xiapex: 0,58 mg clostridium histolyticum administered in the dupuytrens cord as discribed in producers manual |
|
| PNF | Experimental | percutaneous needle fasciotomi is performed at affected cords |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xiapex | Drug |
|
| |
| percutaneous needle fasciotomy |
| Measure | Description | Time Frame |
|---|---|---|
| contracture size (degrees) | five years |
| Measure | Description | Time Frame |
|---|---|---|
| contracture size | Contracture size mesured in degrees in each finger joint | post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| contracture size (degrees) | contracture size mesured in degrees in each finger joint | one year |
| contracture size (degrees) | contracture size mesured in degrees in each finger joint |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hallgeir bratberg, MD | Contact | +4790578848 | hbratber@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| hallgeir bratberg, MD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo Universitetssykehus | Recruiting | Oslo | Oslo | 0424 | Norway |
Not provided
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C570746 | xiapex |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
|
| three years |
| quick-Dash | Quick-DASH functional score measured in points. | one, three and five years |
| Pain | Visual Analogue score | one, three, five years |
| Hand disability | Visual Analogue score | oen, three, five years |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |