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Completed

NCT Number: NCT03409666

Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.

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Key information

Conditions

Hip Osteoarthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avascular Necrosis Bone Diseases Connective Tissue Diseases Correction of Functional Deformity Immune System Diseases Joint Diseases Musculoskeletal Diseases Necrosis Noninflammatory Degenerative Joint Disease Osteoarthritis Osteoarthritis, Hip Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bravis

Roosendaal, Netherlands

About this study

A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner.

All potential study subjects will be required to participate in the Informed Consent process.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
  • Correction of functional deformity.
  • Male or female

-≥ 18 and ≤ 70 years of age

  • Subjects willing to return for follow-up evaluations.
  • Subjects able to read and understand Dutch language.

Exclusion criteria

  • active Infection (or within 6 weeks after infection)
  • Sepsis
  • Osteomyelitis
  • Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  • diagnosed Osteoporosis or Osteomalacia
  • Metabolic disorders which may impair bone formation
  • Distant foci of infections which may spread to the implant site
  • Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  • Vascular insufficiency, muscular atrophy or neuromuscular disease.

Treatment and study plan

Taperloc Complete Microplasty stem

Device

Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner

Other names: Total hip arthroplasty

Taperloc Complete Reduced Distal stem

Device

Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner

Other names: Total hip arthroplasty

Primary outcomes

  1. Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA)

    Time frame: 2 years postoperatively

    Migration and rotation in three directions represented by Maximum Total Point Motion (MTMP)

Secondary outcomes

  1. Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty

    Time frame: 2 years postoperatively

    Assessed by difference in the prevalence of stem malalignment, incorrect sizing and subsidence based on radiographic evaluation.

  2. Early Survival Assessed by Counting the Number of Implant Revisions

    Time frame: Immediate post-operatively, 6 weeks, 1 year and 2 years postoperatively

    Assessed by counting the number of implant revisions

  3. Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS)

    Time frame: pre-operatively (within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively

    Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.

    The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)

  4. Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation

    Time frame: 6 weeks, 1 year and 2 years postoperatively

    Assess radiographs for signs of stress shielding, radiolucency and stem alignment.

  5. Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS)

    Time frame: 2 years postoperatively

    The outcomes of the subcategories are scored on a 0 to 100 scale, with 100 indicating no symptoms.

  6. Clinical Performance Measured by Patient Based Outcome EQ5D

    Time frame: 2 years postoperatively

    Each question in the EQ5D assessment can be answered in three ways, indicating no, moderate or extreme problems. Index scores are created with a weight for each dimension, ranging from 0 (health state equivalent to death) to 1 (perfect health). The EQ5D also includes a question about health status, ranging from 0 (worst health) to 100 (best health).

  7. Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS)

    Time frame: pre-operatively(within 3 months of surgery), 6 weeks, 1 year and 2 years postoperatively

    The OHS assesses pain (6 items) and function (6 items) of the hip in relation to daily activities such as walking, dressing, sleeping, etc. The scoring is the following: 0-4 (worst to best) with overall scores ranging from 0-48 where 48 represents the best score.

  8. Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS)

    Time frame: 6 weeks, 1 year and 2 years postoperatively

    The Forgotten Joint Score (FJS) is a questionnaire, which focuses on the awareness of having a joint prosthesis.

    The rationale of this questionnaire is that the ultimate goal in joint arthroplasty resulting in the greatest possible patient satisfaction is the ability to forget the artificial joint. The outcome is scored on a 0 to 100 scale, with a total score of 0 indicating the highest level of awareness of having a joint prosthesis.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 24, 2018
Registry last updated
Jul 14, 2022

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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