Dorsal Versus Volar Approach for CapFlex-PIP© Implantation

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02886078
• Other study ID #: CapFlexRCT
• Status: Terminated
• Phase: N/A
• First received: August 23, 2016
• Last updated: June 15, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• Dorsal approach CapFlex arthroplasty
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
• Volar approach CapFlex arthroplasty
Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Miriam Marks

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active extension of the PIP joint measured with a goniometer		6 months after surgery
Secondary	Subjective function using the Brief Michigan Hand Questionnaire (briefMHQ)		6 months after surgery