Dorsal Versus Volar Approach for CapFlex-PIP© Implantation

Dorsal Versus Volar Approach for CapFlex-PIP© Implantation: a Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Dorsal approach CapFlex arthroplasty; Procedure: Volar approach 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8008
    • Schulthess Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indication for CapFlex-PIP© arthroplasty
• Patient aged 18 years and over
• Informed Consent as documented by signature

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dorsal approach CapFlex arthroplasty; Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.	Procedure: Dorsal approach CapFlex arthroplasty; Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
Active Comparator: Volar approach CapFlex arthroplasty; Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.	Procedure: Volar approach CapFlex arthroplasty; Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Miriam Marks

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 1, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CapFlexRCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share data