Study Stopped
Insufficient recruitment
Dorsal Versus Volar Approach for CapFlex-PIP© Implantation
1 other identifier
interventional
3
1 country
1
Brief Summary
The primary objective is to investigate the active extension six months after implantation of the CapFlex-PIP© arthroplasty, comparing the dorsal with the volar approach. This is a randomized controlled trial including 70 patients with PIP OA indicated for CapFlex arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 16, 2017
June 1, 2017
8 months
August 23, 2016
June 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Active extension of the PIP joint measured with a goniometer
6 months after surgery
Secondary Outcomes (1)
Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)
6 months after surgery
Study Arms (2)
Dorsal approach CapFlex arthroplasty
EXPERIMENTALArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
Volar approach CapFlex arthroplasty
ACTIVE COMPARATORArthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
Interventions
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
Eligibility Criteria
You may qualify if:
- Indication for CapFlex-PIP© arthroplasty
- Patient aged 18 years and over
- Informed Consent as documented by signature
You may not qualify if:
- Revision surgery
- CapFlex-PIP© arthroplasty at the thumb IP joint
- Major surgery at the same finger (e.g. DIP arthrodesis)
- Ulnar/radial deviation of the PIP joint \> 15°
- Patients in which a reconstruction of the collateral ligaments has to be performed
- General medical contraindication to surgery
- German language barrier to complete the questionnaires
- Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
- Pregnancy
- Surgery not planned by Dr. Herren, Dr. Schindele or Dr. Bodmer
- Legal incompetence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Miriam Markslead
Study Sites (1)
Schulthess Klinik
Zurich, 8008, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr. phil.
Study Record Dates
First Submitted
August 23, 2016
First Posted
September 1, 2016
Study Start
October 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 16, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share
No plan to share data