Comparative Study Between the Use of Trapeziometacarpal P... | NCT07101887

Studies
Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis, Focusing on Changes in Pain (Measured With the VAS Scale) and Function (With the Quick-DASH).

NCT07101887

Sponsor

Parc de Salut Mar

Status

Recruiting

Last Update Posted

Aug 3, 2025Actual

Enrollment

61Estimated

Phase

Not Applicable

Conditions

Rizarthrosis

Interventions

Implantation of thumb prosthesis
Burton-Pellegrini technique

Countries

Spain

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

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Jun 30, 2025Actual

Completion Date

Nov 1, 2025Estimated

First Submitted Date

Jul 28, 2025

First Submission Date that Met QC Criteria

Jul 28, 2025

First Posted Date

Aug 3, 2025Actual

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

Jul 28, 2025

Last Update Posted Date

Aug 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).

Detailed Description

Not provided

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

61Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maia Prosthesis group	Experimental		Procedure: Implantation of thumb prosthesis
Trapeziectomy and Burton-Pellegrini technique	Experimental	Remove the trapezium bone and perform a suspensionplasty using a hemi-slip of the flexor carpi radialis tendon	Procedure: Burton-Pellegrini technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of thumb prosthesis	Procedure	Replacing the articular surface of the trapezo-metacarpal joint with a socked-ball prosthesis.	Maia Prosthesis group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS	Pain evaluated by Visual analogic scale (VAS)	1 year
Quick Dash	Function of the arm evaluated by Quick Dash scale	1 year

Secondary Outcomes

Measure	Description	Time Frame
Strength	Strength evaluated with a pressure gauge	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rizarthrosis grade I, II, III

Exclusion Criteria:

Rizarthrosis grade IV
Severe osteoporosis
Metals allergy
Previous surgical interventions related
Malformations in the articular zones that difficult the implant placement

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Valverde Vilamala	Contact	+34 626330598		dvalverde@hmar.cat

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital del Mar	Recruiting	Barcelona		08003	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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