NCT02647619

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

8.5 years

First QC Date

December 29, 2015

Last Update Submit

April 19, 2022

Conditions

Dupuytren Contracture

Keywords

Primary Dd disaseMCP joint

Outcome Measures

Primary Outcomes (1)

  • Reduction in Total Passive Extension Deficit

    5 years

Secondary Outcomes (9)

  • Quick Dash (Disabilities of the shoulder and Hand)

    5 years

  • EQ5D (Euroqol 5 Dimensions)

    5 years

  • Brief MHQ (Michigan Hand Questionare)

    5 years

  • URAM (Unité Rhumatologique des Affections de la Main)

    5 years

  • Jamar grip strength

    1,4,26 weeks and one year.

  • +4 more secondary outcomes

Study Arms (2)

Needle aponeurotomy

ACTIVE COMPARATOR

percutaneous transection or pretendinous palmar dupytren cord

Procedure: Needle aponeurotomy

Xiapex

ACTIVE COMPARATOR

Injection of 0.58 mg collagenase into pretendinous palmar dupytren cord

Drug: Xiapex

Interventions

XiapexDRUG

Injection of collagenase of primary dupytren cord

Also known as: Xiaflex
Xiapex
Needle aponeurotomyPROCEDURE

26 G needle multiple perforation tecqnique with local anesthetic

Also known as: Percutaneous needle fasiotomy
Needle aponeurotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Oslo, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

xiapexMicrobial Collagenase

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CollagenasesMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteases

Study Officials

  • Per-Henrik Randsborg, PhD

    University Hospital, Akershus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 6, 2016

Study Start

October 1, 2013

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)