Observational clinical study of the CE-marked cemented A2(R) short stem

Recruiting

• Conditions: M06; S72; M16; Osteonecrosis; Other rheumatoid arthritis; Coxarthrosis [arthrosis of hip]; M87; Fracture of femur

• Registration Number: DRKS00025152
• Lead Sponsor: ARTIQO GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. The subjects require a primary hip joint replacement and are candidates for an endoprosthetic fitting with the cemented A2® short stem in accordance with the purpose and indications and contraindications of the currently valid version of the instructions for use of the product.
There is no restriction to certain indications within the intended use. Indications and contraindications according to the instructions for use of the cemented A2® hip stem are as follows:

Indications
- Patients with advanced wear of the hip joint due to degenerative and post-traumatic arthrosis or rheumatoid arthritis
- Avascular necrosis of the femoral head
- Acute traumatic fracture of the femoral head or neck, as long as stable anchorage of the implant is guaranteed.

Contraindications
- Acute or chronic infections, local or systemic
- Severe muscular, nervous or vascular diseases that may endanger the affected extremities
- Fractures tangential to or extending beyond the base of the femoral neck which radiate into the trochanteric region or the calcar.
- Missing or deficient bone substance, which endangers the stable fit of the prosthesis
- Previous operations which no longer provide the intended support
- Pronounced coxa valga with a femoral neck angle >145°
- Pronounced coxa vara with a femoral neck angle <120°
- Any concomitant disease that may jeopardize the function of the implant
- Revision with extensive bone defects

Precautions / Restrictions
As with all hip prostheses, the cemented A2® Short Stem should be used with special caution in patients with:
- Dysplasia coxarthrosis
- severe antetorsion of the femoral neck
- wide femoral neck
- BMI > 30

2. Subjects are willing and physically and mentally able to participate in the clinical trial and intend to be available for the scheduled follow-up visits.

3. Normal motor function of the lower extremities, documented by clinical examination and absence of anamnestic evidence of neurological disease with alteration of motor function.

4. Subjects with age = 18 years.

5. Subjects with a life expectancy of >5 years, as far as assessable by the investigator.

Exclusion Criteria

a) Pre-operative exclusion criteria
1. Previous bony or soft tissue surgery on the affected proximal femur (e.g., varicose osteotomy). Arthroscopic surgery is excluded.
2. Infection of the affected hip joint or systemic infection.
4. CCD angle above 145°.
5. CCD angle below 120°.
6. Proven allergy to components of the implanted prosthesis.
7. Known neurological disease with alteration of motor function, neurological function, as well as neurological or mental illnesses, which may affect an objective assessment of the patient's state of health or an evaluation of his hip joint.
8. Pregnant or lactating women and those who are planning to become pregnant in the next to 2 years (+3 weeks) according to the index procedure.
9. BMI over 32
10. Known alcoholism or other relevant addictive diseases.

b) Intra-operative exclusion criteria
1. Intra-operative circumstances that would allow implantation of a prosthesis other than the type of prosthesis envisaged in the study.
(as determined by the surgeon).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint for the study is the revision rate at ten years postoperatively.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include the following postoperative outcomes:<br>- Evaluation of function, range of motion, and pain using the Harris Hip Score (HHS)<br>- Evaluation of pain and function using Hip Dysfunction and Osteoarthritis Outcome Score Short Form (HOOS-PS)<br>- Evaluation of residual symptoms using the Forgotten Joint Score (FJS-12)<br>- radiographic changes, defined as radiolucent lines, osteolysis, remodeling of the cortical bone, loosening of the implant and (macroscopically visible) migration of the stem<br>- any revisions<br>- Intraoperative, early postoperative, and postoperative complications