Dorsal Versus Volar Approach for CapFlex-PIP© Implantation

Not Applicable

Terminated

• Conditions: Osteoarthritis
• Interventions: Procedure: Volar approach CapFlex arthroplasty; Procedure: Dorsal approach CapFlex arthroplasty

• Registration Number: NCT02886078
• Lead Sponsor: Miriam Marks

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.

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-01
• Study Start: 2016-10
• Status Verified: 2017-06
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-15
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar approach CapFlex arthroplasty	Volar approach CapFlex arthroplasty	Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
Dorsal approach CapFlex arthroplasty	Dorsal approach CapFlex arthroplasty	Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.

Primary Outcome Measures

Name	Time	Method
Active extension of the PIP joint measured with a goniometer	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)	6 months after surgery

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland