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Active, Not Recruiting

NCT Number: NCT04255966

Plasmafit® Revision Structan® Hip Endoprosthesis Cup

The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Osteolysis Arthritis Arthroplasty Complications Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Bone Resorption Connective Tissue Diseases Degenerative Osteoarthritis Femoral Fractures Femoral Head Avascular Necrosis Femur Head Necrosis Fractures, Bone Fractures, Hip Gram-Positive Bacterial Infections Hip Fractures Hip Injuries Infections Instability of Prosthetic Joint Joint Diseases Leg Injuries Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Rheumatic Arthritis Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopädische Klinik König-Ludwig-Haus, Würzburg, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)
  • Written informed consent
  • Cases where a press-fit cup fixation is possible

Exclusion criteria

  • Patients < 18 years
  • Pregnant patients
  • Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)
  • Patient has an infection in the hip joint region

Treatment and study plan

Plasmafit® Revision Structan®

Device

Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Primary outcomes

  1. Harris Hip Score (Functional results of the operated hip) over time

    Time frame: up to five years postoperatively

    The functional results of the operated hip will be assessed with the Harris Hip Score (HHS) and evaluated over time

Secondary outcomes

  1. Survival of the implant

    Time frame: up to five years postoperatively

    Any removal or exchange of the acetabular cup or the polyethylene inlay is defined as revision.

    A removal of the stem is not evaluated as acetabular revision but will be documented and evaluated as part of postoperative complications.

    The revision-free survival will be assessed using the Kaplan-Meier method.

  2. Quality of Life over time

    Time frame: up to five years postoperatively

    EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of three responses reflecting severity (no problems/some or moderate problems/extreme problems).

  3. Radiological Assessment: Osseointegration of the cup over time

    Time frame: at 3 months, 24 months, 5 years follow-up

    The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for osteolysis the implant, to allow an estimation of the osseous integration and stability of the implant.

  4. Radiological assessment: Radiographic loosening of the cup over time

    Time frame: at 3 months, 24 months, 5 years follow-up

    The acetabular component in AP view is divided into the three regions I-III as defined by DeLee-Charnley. All three regions will be assessed for and radiolucent lines around the implant, to allow an estimation of the osseous integration and stability of the implant.

  5. Technical problems during surgery

    Time frame: Intraoperative

    Technical problems with instruments, implants or containers, instrument related issues

  6. Impingement

    Time frame: Intraoperative

    The incidence of impingement during intraoperative mobilization is documented;

  7. General handling of instruments / containers

    Time frame: Intraoperative

    Complaints or problems with the handling of instruments, implants or containers, instrument related issues

  8. Complications

    Time frame: up to 5 years postoperatively

    All complications in the postoperative course are recorded

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study title

Prospective, Multi-centric, Comparative, Long-term Clinical Follow-Up Study for the Evidence of Safety and Performance Indicators of the Plasmafit® Revision Structan® Hip Endoprosthesis Cup

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Feb 5, 2020
Registry last updated
May 6, 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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