Comparison of ARPE Prosthesis With the Literature

NCT01904019 | Completed Results

• 1 other identifier: ORTHO.CR.E16
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy with ligament reconstruction and tendon interposition (LRTI), as published in a recent meta-analysis.

Conditions

Arthritis

Keywords

arthroplasty; trapezio-metacarpial

Outcome Measures

Primary Outcomes (4)

• Grip Strength

  Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.

  Pre-operative, 1, 3 and 5 years follow-up

• Key Pinch Strength

  Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.

  Pre-operative, 1, 3 and 5 years follow-up

• Tip Pinch Strength

  Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.

  Pre-operative, 1, 3 and 5 years follow-up

• VAS Pain

  Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain).

  Pre-operative, 1, 3 and 5 years follow-up

Secondary Outcomes (8)

• Motion - ROM Measurement - Radial Abduction

  Pre-operative, 1, 3 and 5 years follow-up

• Motion - ROM Measurement - Palmar Abduction

  Pre-operative, 1, 3 and 5 years follow-up

• EQ-5D - Health Status Score

  Pre-operative, 1, 3 and 5 years follow-up

• EQ-5D - VAS Score

  Pre-operative, 1, 3 and 5 years follow-up

• Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis

  1, 3 and 5 years follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring a trapeziometacarpal arthroplasty to replace the trapeziometacarpal joint and restore its function.

You may not qualify if:

• patients with trapezio-metacarpal arthritis Eaton Stage of trapezio-metacarpal arthritis: Stage II - IV
• patients willing to return for follow up evaluation.
• local or systemic infections
• severe muscular, neurological or vascular deficiencies of the extremity involved
• bone destruction or poor bone to affect implant stability
• allergy to any of the components of the implant

Sponsors & Collaborators

• Zimmer Biomet: lead
• Biomet Belgium BVBA: collaborator

Study Sites (1)

SPM Deurne

Deurne, 2100, Belgium

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Emilie Rohmer, Clinical Operations Manager
• Organization: Zimmer Biomet

Emilie.Rohmer@zimmerbiomet.com

+41 58 85 48210

Study Officials

• Frederik VERSTREKEN, PhD

  SPM Deurne

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: July 19, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2020
• Study Completion: May 1, 2021
• Last Updated: October 18, 2021
• Results First Posted: August 23, 2021

Record last verified: 2021-09

Locations

BE (1)