Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dupuytren´s Disease Study. Primary Disease, MCP Joint, Xiapex, PNF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02647619
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ingi Thor Hauksson, University Hospital, Akershus

Brief Summary:

Aim:

Clinical RCT comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy.

Materials and methods:

30° or more contracture of only one metacarpophalangeal (MCP) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (PIP) joint. Patients with primary disease of the hand. Total of 80 patients needed to detect difference of 13.5°.

1) Needle aponeurotomy 2) Clostridium Histolyticum treatment. Clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. Functional outcome scores: URAM, Quick Dash, EQ5D, brief MHQ, VAS pain and VAS patient satisfaction. Total passive extension contracture reduction, recurrence rate and registration of complications.


Condition or disease Intervention/treatment Phase
Dupuytren Contracture Drug: Xiapex Procedure: Needle aponeurotomy Phase 4

Detailed Description:

Open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for Dupytren´s disease (Dd) despite considerable risk of complications.

There is an increasing interest in Scandinavia in the treatment of Dd with Clostridium Histolyticum (Xiapex ®, Auxillium). However the enzyme is expensive and long-term effects are not well documented. More studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis.

The treatment arm of Xiapex in this study follows the recommendation as by the producer.

The other treatment of Dd contracture in this study is needle fasiotomy/aponeurotomy. We use multiple perforation technigue with 26 G needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended.

The two procedures leave little scar tissue lessening the challenges posed by the reoperations.

Recurrence rate of contracture following different treatments of Dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial (RCT) Comparing Clostridium Histolyticum With Needle Aponeurotomy.
Actual Study Start Date : October 2013
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Needle aponeurotomy
percutaneous transection or pretendinous palmar dupytren cord
Procedure: Needle aponeurotomy
26 G needle multiple perforation tecqnique with local anesthetic
Other Name: Percutaneous needle fasiotomy

Active Comparator: Xiapex
Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord
Drug: Xiapex
Injection of collagenase of primary dupytren cord
Other Name: Xiaflex




Primary Outcome Measures :
  1. Reduction in Total Passive Extension Deficit [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quick Dash (Disabilities of the shoulder and Hand) [ Time Frame: 5 years ]
  2. EQ5D (Euroqol 5 Dimensions) [ Time Frame: 5 years ]
  3. Brief MHQ (Michigan Hand Questionare) [ Time Frame: 5 years ]
  4. URAM (Unité Rhumatologique des Affections de la Main) [ Time Frame: 5 years ]
  5. Jamar grip strength [ Time Frame: 1,4,26 weeks and one year. ]
  6. VAS (Visual analogue scale) pain [ Time Frame: 1,4,26 weeks and one year ]
    0 is no pain, 10 maximum pain

  7. VAS (Visual analogue sale) satisfaction [ Time Frame: 1,4,26 weeks. 1,2 and 5 years ]
    0 is not satisfied, 10 maximum satisfied

  8. Complications [ Time Frame: 1,4,weeks One year ]
    AE,SAE,SUSAR

  9. Recurrence [ Time Frame: 1,4,26 weeks. 1,2 and 5 years ]
    def. 30 degrees of treated MCP joint, or 20 or more degrees of adjecent PIPJ



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary Dd disease (no earlier treatment for this condition of the hand involved)
  • Single digit involvement, one of the three ulnar digits
  • Average norwegian language skills.
  • MCPJ contracture of 30 degrees or more and less than 20 degree involvement of the adjacent PIPJ
  • Minimum 18 y.o.

Exclusion Criteria:

  • Involvement of 2 fingers/joints
  • Earlier treatment for Dd disease of the same hand, affection of addjecent PIPJ of 20 degrees or mor
  • Pregnancy
  • Ongoing treatment with platelet inhibitors
  • Treatment with tetracycline 2 weeks prior to treatment date
  • Poor norwegian language skills
  • Participation in other studies 4 weeks prior or after treatment date
  • "Need to treat" of both hands

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647619


Locations
Layout table for location information
Norway
Akershus University Hospital
Oslo, Akershus, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Layout table for investigator information
Study Director: Per-Henrik Randsborg, PhD University Hospital, Akershus

Layout table for additonal information
Responsible Party: Ingi Thor Hauksson, MD, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02647619     History of Changes
Other Study ID Numbers: 2639063
2013-001221-13 ( EudraCT Number )
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ingi Thor Hauksson, University Hospital, Akershus:
Primary Dd disase
MCP joint

Additional relevant MeSH terms:
Layout table for MeSH terms
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases