Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

NCT05267964 | Unknown

• 1 other identifier: 26-543 ex 13/14
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rhizarthrosis is a frequently occurring pathology leading to severe limitations in daily life due to pain and loss of function. Good clinical results have been reported for some carpometacarpal (CMC) joint prosthesis designs, but high failure rates due to loosening and dislocation must be considered. The study aim was to investigate a new, double mobility CMC-prosthesis design with special focus on (1) the functional outcome and (2) patient quality of life (QOL)

Conditions

Arthropathy of Hand

Outcome Measures

Primary Outcomes (5)

• Functional outcome- Thumb opposition

  Measurement of thumb opposition (scale from 1 to 10) range according to Kapandji. A score of 0 indicates no opposition, a score of 10 indicates maximal opposition.

  twelve months postoperative

• Functional outcome - Thumb retropulsion

  Measurement of thumb retropulsion (scale from 1 to 3) range according to Kapandji

  twelve months postoperative

• Functional outcome - maximal palmar abduction

  measurement of the maximal palmar abduction using a goniometer.

  twelve months postoperative

• Functional outcome - maximal radial abduction

  measurement of the maximal radial abduction using a goniometer.

  twelve months postoperative

• Functional outcome - tip-to-tip force

  The tip-to-tip force (between thumb and index finger) was measured in Newton (N) using a handheld dynamometer (Cit Technics, Haren, Netherlands).

  twelve months postoperative

Study Arms (2)

Epping resection arthroplasty

ACTIVE COMPARATOR

During the Epping resection-suspension arthroplasty the trapeziectomy is performed, the flexor carpi radialis tendon is divided into two parts and one of these is stripped and cut proximally. To prevent shortening of the first ray with following loss of strength, this tendon strip is pulled through a drill hole in the base of the 1st metacarpal from ulnar palmar to radial dorsal. The rest of the tendon strip is sutured to a roll replacing the os trapezium.

Procedure: Epping resection arthroplasty

CMC I prosthesis group

ACTIVE COMPARATOR

During implantation of the prosthesis the CMC joint is opened and 3 mm of the metacarpal base as well as osteophytes are resected. Following the release of the trapezium the first metacarpal and the trapezium are prepared for the prosthesis by broaching and drilling. After the test-implants have shown satisfying joint tension and anatomic conditions, the HA coated stem and cup are pressfit inserted in the appropriate size followed by the modular head.

Procedure: CMC I prosthesis

Interventions

Epping resection arthroplasty PROCEDURE

Follwing the described epping resection arthroplasty, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.

Epping resection arthroplasty

CMC I prosthesis PROCEDURE

Follwing the described CMC I prosthesis procedure, The first ray was immobilized using an orthosis for four weeks postoperatively in both study groups followed by eight weeks of physical therapy.

CMC I prosthesis group

Eligibility Criteria

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

You may qualify if:

• symptomatic rhizarthrosis grade 2 and 3 according to Eaton's classification,
• failed conservative treatment prior to surgery,
• written informed consent to the study.

You may not qualify if:

• scaphotrapezotrapezoidal (STT) arthrosis,
• former CMC joint surgery,
• patients under custodianship.

Sponsors & Collaborators

• Medical University of Graz: lead
• Stryker Instruments: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients are radomized into two groups prior to the surgical intervention using the radomizing programm of the medical university of graz.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 7, 2022
• Study Start: November 1, 2014
• Primary Completion: November 30, 2019
• Study Completion: April 1, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02