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NCT Number: NCT03168750

Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component

This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

Up to 75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tucson Othropedic Institute, Oro Valley, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Primary osteoarthritis of the hip necessitating primary hip replacement,
  • Suitability for straight cementless stem,
  • Adult male and female under 75 years old,
  • Ability to give informed consent ,
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up.

Exclusion criteria

  • Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component
  • Post-traumatic deformity in the affected hip,
  • Patient suffering from Inflammatory arthritis including rheumatoid arthritis,
  • Patient suffering by congenital or developmental deformity,
  • Severe osteoporosis,
  • History of surgery in the affected hip,
  • Perioperative fracture,
  • Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain,
  • Patients with a history of active infection
  • Pregnant women or those seeking to become pregnant

Treatment and study plan

Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.

Device

Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.

Primary outcomes

  1. Harris Hip Score (HHS)

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score

  2. Hip Disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score

  3. Oxford Hip Score (OHS)

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score

  4. Veterans Rand 12 (VR-12)

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Assessment of the improvement in your health using the Veterans Rand 12

  5. EuroQol 5 dimension (EQ-5D)

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Assessment of the improvement in quality of life and joint movement using the EQ-5D

Secondary outcomes

  1. Radiographic analysis

    Time frame: pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative.

    Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar.

Sponsors and collaborators

Lead sponsor

Medacta USA

Industry

Registry information

Official study title

Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
May 30, 2017
Registry last updated
Nov 21, 2024

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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