Continuum™ Metal Bearing System in Total Hip Arthroplasty

Completed

Conditions: Avascular Necrosis
Inflammatory Arthritis
Osteoarthritis
Post-traumatic; Arthrosis
Total Hip Arthroplasty

Registration Number: NCT03382652

Lead Sponsor: Zimmer Biomet

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 83

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)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Survival at 10 Years	1, 2, 3, 5, 7, and 10 years postop.	The primary endpoint for this study is implant survival at 10 years which was assessed by revision either of the Continuum Cup or the Metasul liner. A success rate for the experimental group was calculated using the Kaplan-Meier Survival Estimation.

Secondary Outcome Measures

Name	Time	Method
Radiographic Evaluations	Immediate-postop, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op.	Radiographic evaluation was performed in order to identify potential adverse events. Investigators at each site were responsible for reviewing the radiological images for any abnormal or significant findings and reporting adverse events if applicable. In addition, an independent radiographic reviewer performed assessments of radiographic films in terms of evidence of radiolucencies, osteolysis, subsidence, acetabular cup migration, and change in acetabular cup angle at 6 months, 1 year and 2 year post-operation. Outcomes included numbers of reported findings per anatomical position and time point.
Metal Ion Concentration in Blood	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.	Metal ion levels (cobalt, chromium and titanium) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
The Harris Hip Score (HHS)	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op	The Harris hip Score (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care Professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). The total score can vary from a range of 0 - 100. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70.
The Subject Quality-of-Life (SF-12): Physical and Mental Socres	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op	SF12: The SF-12 is a multipurpose short-form (SF) generic measure of health status. It consists of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). Scores ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.
EQ5D	Pre-op, 6 weeks, 6 months, 1, 2, 3, 5, 7, and 10 years post-op	EQ5D: The EQ-5D is a standardized Instrument widely used to measure health status. It is a self reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes 5 questions referring to mobility, self care, daily activities, pain/discomfort, and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573; negative numbers correspond to a self-assessed health state worse than being dead. The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The warst health you can imagine') where the patient reports his/her self-rated health.
Creatine Concentration and BUN	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.	Renal function (BUN and Creatinine) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.
Calculated GFR	Pre-op, 6 months, 1 year, 2 years and 5 years Post-Op.	Renal function (BUN, Creatinine and GFR) were analyzed by an approved Central Laboratory at the time points listed below for all study subjects enrolled in this study. In addition, prior to a revision surgery, a blood draw for metal ion data collection was performed.

Trial Locations

Locations (3): Jokilaakson terveys oy
🇫🇮
Jämsä, Finland
Saint Davids Medical Center
🇺🇸
Austin, Texas, United States
Hospital District of Southwest Finland
🇫🇮
Turku, Finland