Clinical trial NCT03382652: Continuum™ Metal Bearing System in Total Hip Arthroplasty
Official title: Continuum™ Metal Bearing System in Total Hip Arthroplasty- A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Avascular Necrosis
Osteoarthritis
Inflammatory Arthritis
Post-traumatic; Arthrosis
Total Hip Arthroplasty
Keywords: Total hip arthroplasty
Medical Device
Post Market Surveillance Study
Performance
Safety
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-12-26
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be comprised of max. 100 males and females who require primary total hip arthroplasty. Subjects will be enrolled at 3 investigative centers. Subjects must be geographically accessible throughout the study and be willing and able to attend required follow-up appointments. Candidates who express interest in study participation will be offered informed consent, and eligibility will be determined based upon the inclusion/exclusion criteria.

Brief summary: The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and outcome data on the Continuum Metal Bearing System in primary total hip arthroplasty.

Detailed description: The subject of this clinical investigation is the Continuum Metal Bearing THA System in primary total hip arthroplasty. This system consists of a cementless modular Trabecular Metal® (TM) Continuum Acetabular Shell, a modular Metasul Taper liner, and a modular Metasul femoral head. The characteristics of this THA system may allow for reduction in wear and osteolysis as compared to other approved and marketed THA systems and thus increase the expected implant life.

In total, 3 sites were involved. This number of clinical sites permitted assessment of the consistency among a multitude of investigators. A total number of 83 were included in the study.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 to 75 years of age, inclusive.
* Patient is skeletally mature.
* Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:

  * Avascular necrosis (AVN) Osteoarthritis (OA)
  * Inflammatory arthritis (i.e. Rheumatoid arthritis)
  * Post-traumatic arthritis
* Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
* Patient has a Harris Hip Score \<70 in the affected hip
* Patient is willing and able to provide written informed consent.
* Patient is willing and able to cooperate in the required post-operative therapy.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
* Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.

Exclusion Criteria:

* The patient is:

  * A prisoner
  * Mentally incompetent or unable to understand what participation in the study entails
  * A known alcohol or drug abuser
  * Anticipated to be non-compliant.
* The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* The patient has a neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
* The patient has a diagnosed systemic disease that could affect his/her safety or the study outcome.
* The patient is known to be pregnant.
* The patient is unwilling or unable to give consent, or to comply with the follow-up program.
* The patient has received an investigational drug or device within the previous 6 months.
* The patient has an active or latent infection in or about the affected hip joint or an infection distant from the hip joint that may spread to the hip hematogenously. The patient has insufficient bone stock to fix the component. Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis), cancer, and radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the presence of adequate bone stock.
* The patient has known local bone tumors and/or cysts in the operative hip.
* The patient has a known allergic reaction to one or more of the implanted material.
* The patient is Grade III obese with a Body Mass Index (BMI) ≥ 40.
* The patient has osteoradionecrosis in the affected hip joint
* Kidney insufficiency (Kidney insufficiency will be determined based on eGFR value.

See Blood Analysis Report CRF for details)

Primary outcomes:
measure: Implant Survival at 10 Years
timeFrame: 1, 2, 3, 5, 7, and 10 years postop.
Secondary outcomes:
measure: The Harris Hip Score (HHS)
timeFrame: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
measure: The Subject Quality-of-Life (SF-12): Physical and Mental Socres
timeFrame: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
measure: Radiographic Evaluations
timeFrame: Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.
measure: Metal Ion Concentration in Blood
timeFrame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
measure: EQ5D
timeFrame: Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op
measure: Creatine Concentration and BUN
timeFrame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
measure: Calculated GFR
timeFrame: Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Saint Davids Medical Center
state: Texas
city: Jämsä
country: Finland
facility: Jokilaakson terveys oy
city: Turku
country: Finland
facility: Hospital District of Southwest Finland
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: