A Post-market Study Evaluating Clinical and Radiographic Outcomes of Total Elbow Arthroplasty With TEMA

Not Applicable

Not yet recruiting

• Conditions: Total Elbow Arthroplasty
• Interventions: Device: TEMA elbow system

• Registration Number: NCT05180071
• Lead Sponsor: Limacorporate S.p.a

Brief Summary

TEMA elbow system is a CE marked medical device, and within this clinical trial it is used according to its intended use. This is a Post Marketing Clinical Follow Up trial, with the main aim to collect evidences on the outcome data on this product, by analysing clinical scoring systems, radiographs and adverse event records within five years after the surgery, and thus to assess the short-term performance and safety of this implant.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Study Start: 2024-02-01
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. Patient's age ≥ 18 years old.

2. Patient has given written informed consent to participate to the trial and to his/her personal data processing

3. According to the device indications for use, patient suffers from disability due to one or more of the following:

   • Elbow joint destruction which significantly compromises the activities of daily living
   • Non-Inflammatory degenerative joint disease including osteoarthritis and avascular necrosis with hemophilia.
   • Rheumatoid arthritis or degenerative arthritis with incapacitating pain
   • Correction of severe functional deformity.
   • Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
   • Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
   • Any other medical reason that the investigator determine that subject is a good candidate for a total elbow arthroplasty

4. Patient has undergone a total elbow arthroplasty, receiving TEMA prosthesis.

5. Patient is able to comply with the study protocol.

Exclusion Criteria

A patient will be excluded from the study participation if he/she meets any of the following criteria:

1. Patient is affected by one or more of the conditions that are stated as TEMA contraindications for use, which are:

   • Local or systemic infection;
   • Septicemia;
   • Persistent acute or chronic osteomyelitis.
   • Uncooperative patient or patient with neurologic disorders who are incapable of following directions;
   • Osteoporosis;
   • Metabolic disorders which may impair bone formation;
   • Rapid joint destruction, marked bone loss or bone resorption.

2. Patient suffers from a diaphyseal fracture

3. For female patients, current pregnancy and/or lactation or planning a pregnancy.

4. Only for patients implanted with the unlinked configuration of TEMA prosthesis, the intraoperative testing showed a bad quality of medial and lateral elbow ligaments.

5. Patient is enrolled in another investigational drug/device study that in the opinion of the Investigator could interfere with this clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TEMA elbow arthroplasty	TEMA elbow system	-

Primary Outcome Measures

Name	Time	Method
Oxford Elbow Score improvement at three ears FU	2 years Follow up	Functional change in Oxford Elbow Score (OES) from preoperative (baseline) to 2 years of follow-up.