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NCT Number: NCT04943328

Cemented TrendHip® - Multicenter PMCF Study on Total Indications

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Coxarthrosis; Primary Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Coxarthrosis; Post-Traumatic Femoral Fractures Femur Head Necrosis Fractures, Bone Fractures, Hip Hip Dislocation Hip Dysplasia Hip Fractures Hip Injuries Immune System Diseases Joint Diseases Joint Dislocations Leg Injuries Musculoskeletal Diseases Necrosis Necrosis, Femur Head Osteoarthritis Osteoarthritis, Hip Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Franziskus-Hospital, Ahlen, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion: Inclusion criteria

  • 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.

Exclusion: Exclusion criteria

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

Treatment and study plan

Total hip arthroplasty

Device

cemented hip arthroplasty

Other names: TrendHip®

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Pain Assessment

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

    Pain will be measured with a Visual Analogue Scale (VAS), at rest and when walking on flat ground. The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patients are asked to mark their current pain level on the line.

  2. Patient satisfaction with surgery result

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

    Patient is asked for satisfaction with surgery result with a 4-point scale: very satisfied, satisfied, unsatisfied, very unsatisfied

  3. Survival rate (Kaplan-Meier)

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

    The survival of the TrendHip® Total Hip Prothesis will be analyzed using the "Kaplan-Meier".

  4. Radiological Outcome: Migration of the stem in mm

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

    Migration of the stem is assessed in [mm] relative to postoperative x-rays

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

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

    Bony Osseointegration or conspicuous features of the stem are assessed on anterior-posterior and lateral x-rays of the stem and will be analysed according to the zones defined by Gruen. "Charnley" and "Gruen" zones of the hip are distinct zones used in assessment of aseptic loosening in total hip joint replacements

  6. Radiological Outcome: Heterotopic Ossification

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

    Brooker classification divides heterotopic ossifications that form following total hip replacement to four classes. Class I: islands of bone within soft tissues around hip; Class II: bone spurs in pelvis or proximal end of femur leaving ≥1 cm between the opposing bone surfaces; Class III: bone spurs that extend from pelvis or the proximal end of femur, which reduce the space between the opposing bone surfaces to <1cm; Class IV: ankylosis of the hip on x-ray

Other outcomes

  1. Rate of Adverse and Serious Adverse Events

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

    All Adverse Events (AE) / Serious Adverse Events (SAE) observed during the follow-up examination or reported by the patient will be documented. Only those AE and SAE that could be related to the investigational product or the TrendHip® Total Hip Arthroplasty procedure are of interest.

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Post Market Clinical Follow-Up (PMCF) Study to Evaluate the Performance and Safety of the Cemented TrendHip® Stem in a Prospective Follow-up Study

Acronym: TRESTI

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Jun 29, 2021
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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