Dorsal Versus Volar Approach for CapFlex-PIP© Implantation | NCT02886078

Studies
Dorsal Versus Volar Approach for CapFlex-PIP© Implantation

NCT02886078

Sponsor

Miriam Marks

Status

Terminated

Last Update Posted

Jun 16, 2017Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Dorsal approach CapFlex arthroplasty
Volar approach CapFlex arthroplasty

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Aug 23, 2016

First Submission Date that Met QC Criteria

Aug 31, 2016

First Posted Date

Sep 1, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2017

Last Update Posted Date

Jun 16, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The CapFlex-PIP© implant is a modular gliding surface proximal interphalangeal (PIP) joint prosthesis. For implantation, there are two approaches available: The dorsal central split approach according to Swanson and the volar approach described by Simmen.

Our experiences and data from our prospective registry indicate, that the active extension of the PIP joint is better after the dorsal approach, but sometimes related with hyperextension of the PIP joint and secondary swan-neck deformity. Extension is supposed to be better after the volar approach, but associated with active and passive extension lag. Evidence of theses experiences will assist the surgeon in the preoperative planning to select the appropriate approach according to the patient's needs.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dorsal approach CapFlex arthroplasty	Experimental	Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.	Procedure: Dorsal approach CapFlex arthroplasty
Volar approach CapFlex arthroplasty	Active Comparator	Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.	Procedure: Volar approach CapFlex arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dorsal approach CapFlex arthroplasty	Procedure	Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.	Dorsal approach CapFlex arthroplasty

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Active extension of the PIP joint measured with a goniometer		6 months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)		6 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient aged 18 years and over
Informed Consent as documented by signature

Exclusion Criteria:

Revision surgery
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Schulthess Klinik		Zurich		8008	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided