Cemented TrendHip® - Multicenter PMCF Study on Total Indications

NCT04943328 | Active Not Recruiting

• 1 other identifier: AAG-O-H-2105
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 4

Brief Summary

This Post Market Clinical Follow-Up (PMCF) study to evaluate the performance and safety of the cemented TrendHip® stem in a prospective follow-up study with patients who underwent a hip arthroplasty with the investigational product (representative of usual clinical practice), at two follow-up examinations

Conditions

Fractures, Hip; Hip Dysplasia; Coxarthrosis; Primary; Coxarthrosis; Post-Traumatic; Necrosis, Femur Head; Rheumatoid Arthritis

Keywords

Total Hip Arthroplasty; Hip Prosthesis; Elderly Patients; Bone Cement

Outcome Measures

Primary Outcomes (1)

• Change of functional outcome over five year follow-up period (modified Harris Hip Score)

  The modified Harris Hip Score (mHHS) as patient-reported outcome measure and evaluated one-year and five-years postoperatively. The mHHS is a validated and disease-specific instrument commonly used to assess outcomes in total hip arthroplasty. The domains covered are pain, function (gait), and functional activities.

  preoperative (as available) and at two examinations during Follow-Up (1 year postop, 5 years postop)

Secondary Outcomes (6)

• Pain Assessment

  at two examinations during Follow-Up (1 year postop, 5 years postop)

• Patient satisfaction with surgery result

  at two examinations during Follow-Up (1 year postop, 5 years postop)

• Survival rate (Kaplan-Meier)

  at two examinations during Follow-Up (1 year postop, 5 years postop)

• Radiological Outcome: Migration of the stem in mm

  at two examinations during Follow-Up (1 year postop, 5 years postop)

• Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem

  at two examinations during Follow-Up (1 year postop, 5 years postop)

Other Outcomes (1)

• Rate of Adverse and Serious Adverse Events

  at two examinations during Follow-Up (1 year postop, 5 years postop)

Study Arms (1)

TrendHip®

OTHER

Device: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty DEVICE

cemented hip arthroplasty

Also known as: TrendHip®

TrendHip®

Eligibility Criteria

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

You may qualify if:

• Patient older than 18 years.
• Patient who undergo / underwent a hip arthroplasty with cemented TrendHip® femoral stem according to the indications for implantation specified in the Instructions for Use.
• Patient not opposing participation in the study.

You may not qualify if:

• Patient with shortened life expectancy.
• The patient is unable to commit to the planned follow-up period.

Sponsors & Collaborators

• Aesculap AG: lead

Study Sites (4)

St. Franziskus-Hospital

Ahlen, North Rhine-Westphalia, 59227, Germany

Location

St. Vincenz Hospital Brakel

Brakel, 33034, Germany

Location

St. Marien-Hospital

Mülheim, 45468, Germany

Location

radprax Krankenhaus Plettenberg GmbH

Plettenberg, 58840, Germany

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Arthritis, Rheumatoid; Hip Fractures; Hip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Joint Dislocations

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: June 29, 2021
• Study Start: October 12, 2021
• Primary Completion: May 8, 2023
• Study Completion (Estimated): May 8, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

DE (4)