Trapeziometacarpal Prosthesis vs. Resection-Interposition Arthroplasty

NCT ID: NCT05267964

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-01
• Study Completion Date: 2022-04-01

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)

Detailed Description

The Epping resection-suspension arthroplasty procedure was described in 1983 to address the proximal migration of the first ray while providing pain free grip strength without any implants. It has shown rather good functional outcome and pain relief. A reduction in thumb opposition strength of 27% compared to the contralateral side and intermittent pain in physical activity is reported, however. Further, studies comparing trapeziectomy and trapeziectomy with tendon interposition recommend trapeziectomy due to the simple technique and comparable outcome.

Endoprosthesis of the first carpometacarpal (CMC) joint represents a different treatment strategy aiming at an exact reconstruction of the joint geometry. Some studies report excellent functional outcome and pain relief. However, there are some prosthesis designs (cemented and uncemented) with high rates of loosening, luxation and poor subjective results. To address these issues, a prosthesis was designed combining a cylindric, double mobility cup and a hydroxyapatite covered stem and cup available in different sizes. The aim of this study was to compare this new prosthesis design to the Epping arthroplasty as the current standard in the investigator's institution regarding (1) the functional outcome with special focus on mobility and strength and (2) patient quality of life (QOL) and pain relief.

Note: The registration of this trial on Clinicaltrials.gov was carried out retrospectively after primary completion of the study.

Conditions

Arthropathy of Hand

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epping resection arthroplasty

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.

Group Type: ACTIVE_COMPARATOR

Epping resection arthroplasty

Intervention Type: 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.

CMC I prosthesis group

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.

Group Type: ACTIVE_COMPARATOR

CMC I prosthesis

Intervention Type: 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.

Interventions

Epping resection arthroplasty

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.

Intervention Type: PROCEDURE

CMC I prosthesis

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Instruments

INDUSTRY

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

26-543 ex 13/14

Identifier Type: -

Identifier Source: org_study_id