Patients receive a cementless GMK Sphere Total Knee Replacement

Knee Osteoarthritis

GMK Sphere TKR

Oslo University Hospital

Stability of Uncemented Medially Stabilized TKA

In Vivo Stability and Bone Quality of an Uncemented Total Knee Arthroplasty With Medially Stabilized Design

X-Y-Z rotations and X-Y-Z translations in degrees and mm

Evaluation of bone quality of the proximal tobia

Radiological evaluation with postoperative conventional radiograph and at 2 years for radiolucencies.
Full-length leg radiographs for evaluation of the axis of the lower extremity

Stephan M Rohrl

ass.professor

Medacta International SA

Randomization between two stem components. LCU or Corail stem.

Randomization between two cup components. DeltaTT or Pinnacle cup.

Osteoarthritis, Hip

Patients are randomized between two types of stem components and two types of cup components in total hip arthroplasty. Thus randomized between 4 different groups.

Randomization between prosthetic components

Orthopedic department, Umeå University hospital

Umeå University hospital

A Comparative Study of Stem and Cup Fixation and Polyethylene Wear

Link LCU + Lima Delta TT vs DePuy Corail + Pinnacle. A Comparative Study of Stem and Cup Fixation and Polyethylene Wear

Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs. Radiostereometric analysis (RSA) is a stereo X-ray technique used in clinical research studies to evaluate micro-motion and wear of orthopaedic implants within bone. The method has a high accuracy and precision. Technical requirements include the need for implanted marker beads and radiograph view angles determined by a calibration cage.

Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs.

The size of the femoral component penetration into the polyethylene measured in millimeters per year and the volumetric annual wear millimetres with radiostereometric (RSA) analysis of radiographs.

Movements between the polyethylene liner and the metal shell of the Delta TT millimetres with radiostereometric (RSA) analysis of radiographs measured in millimeters per year.

Hip disability and Osteoarthritis Outcome Score is a disease specific patient reported outcome measures ranging from 0-100 points. Obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

Harris Hip score is a patient reported outcome measure which include questions regarding the function of the treated hip. Obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

A general health related quality of life questionnaire of which a score i calculated (-0,594-1.0). Obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

Visual Analog Scale (0-100 points) obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

Patient reported outcome measure for evaluating activity University of California, Los Angeles (UCLA) activity scale (0-10). Obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

Short Form Health Survey (0-100 points) is a general health related quality of life patient reported outcome measure Obtained preoperatively, and at all postoperative follow-ups 6 weeks, 3, 12 months, 2, 5, 10 and 15 years.

Kjell G Nilsson

Professor

Umeå University

Control: Corail femoral stem and Pinnacle cup with Marathon XLPE neutral liner (DePuy Orthopaedics).
Study: LCU femoral stem (Waldemar Link GmbH) and Delta TT cup with Neutral XLPE liner (Lima Corporate).

Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections.
50 patients for re-intervention of hip prosthesis with friction couples of: ceramic-on-ceramic or metal-on-metal
(25 patients by group)

Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections.
50 patients for re-intervention of hip prosthesis of stainless steel ball.

Re-intervention surgery: blood, urine, hair, synovial fluid and peri-prosthetic tissue collections.
50 inpatient subjects for re-intervention of knee prosthesis polyethylene-on-metal.

Autopsy: 80 dead patients IMD holders will be autopsied.

Autopsy: dead patients non-IMD holders autopsied, 30 subjects in this arm.

Before the initial prosthesis surgery: 30 patients Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections will be done

Biomarker

Systemic Inflammation

All inpatient subjects: following samples will be collected during hospitalization:
Twice blood and urine collections:
at the beginning of hospitalization: 10 ml of blood + 5 ml of urine;
at the end of hospitalization: 5 ml of blood + 5 ml of urine. Synovial fluid collection: 1 ml Peri-prosthetic tissue collection: about 1 cm3 Hair collection: a single hair of 0.5 cm diameter

Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections

Dead patients will be autopsied: hair, urine, blood, peri-prosthetic tissue and viscera (liver, kidney, spleen, brain, heart, lung) sampling for each autopsy.

Autopsy

Service de Chirurgie orthopédique, Hôpital Raymond Poincaré

Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation

Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
1/ A measure by flow cytometry to identify hyperactivated circulating mononuclear cells (macrophages, dendritic cells, T and B lymphocytes), in contact with trace element nanoparticles and thus, to highlight an immunophenotype of this inflammation.

Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
2/ A measure by multiplex LuminexTM (Bio-plex ProTM human inflammation panel, Bio-rad) to identify specific circulating proteins such as TNF, IFN, cytokines, chemokines, metalloproteins, related to activation of the cells of inflammation throughout release of particles and salting out of trace elements by IMD

Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
- 3/ A macroscopic study of organs to determine the possible presence of tumor foci

Demonstration of systemic inflammation induced by the trace elements existing in IMD with blood and tissue criteria:
- 4/ Cytopathological analysis on slides, after sampling, fixation, inclusion and staining with hematoxylin-eosin-saffron to evaluate semi-quantitatively the type of inflammation (chronic if mononuclear cells or acute if neutrophils) and degree according to the number of inflammatory cells

Trace elements dosing in liquids and tissue by high resolution ICP mass spectrometry in studied sub-population (autopsied IMD holder and non-holder dead subjects, IMD holder living patients with inflammatory reaction and will undergo re-intervention) and in each analyzed material in non-mineralized form, in order to determinate concentrations of free trace elements and after full mineralization to determinate the concentrations of trace elements in nanoparticle form.

Comparison of concentrations of 40 analyzed trace elements in different materials, depending on the groups.

Assistance Publique - Hôpitaux de Paris

30 of the 60 patients will be randomized to cemented cup fixation

30 of the 60 patients will be randomized to cementless cup fixation

Arthropathy of Hip

All patients will preoperatively, 3 months, 1 year, 2 year and 5 year have the hip DXA scanned, answer PROM, X-ray for RSA analysis and wear measurements, and wear accelerometry chip 14 days prior each outward clinic visit for movement analysis.

cup fixation

Avantage® Cup

University Clinic of Hand, Hip and Knee Surgery, Holstebro Hospital

Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis

cup migration in the cemented and cementless cups are measures with Radiostereometric Analysis.
The primary endpoint was proximal cup migration (y-axis) at the 2-year follow-up.

measurement af the plastic (polyethylene) are measured with Radiostereometric Analysis.

Dual energy X-ray Absorption (DXA) scans are made to measure to bone mineral density around the prosthesis.

Patient Reported Outcome Measures (PROM) are collected continuously

3-axis accelerometer. Monitor human movements continuously to determine pre and postoperatively movements, mobility and activity for the assessment of functional ability.
The Activity (AX3) device is securely fastened to the patients hip two weeks preoperatively and again two weeks prior to each outward clinic visit at 3 months, 1 yr, 2 yr and 5 yr.

University of Aarhus

Zimmer Biomet

Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy).

Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link).

Femoral Neck Fractures

Total Hip Arthroplasty

Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).

Cemented Lubinus SPII stem (control arm)

Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).

Uncemented HA Coated Corail stem

Mölndals Hospital (part of Sahlgrenska University Hospital)

Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

Corail-SP Study - A Prospective Randomized Comparison Between Cemented and Uncemented Hydroxyapatite Coated Prosthesis Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).

Cognitive status measured once daily with Pfeiffer's test (Short Portable Mental Status Questionnaire - SPMSQ).
Eventual confusion is noted once daily.

POX-measurements during different phases of surgery along with pulmonary catheter readings.

Blood samples for measurement of the inflammatory response with biochip multi-array technology.

Measured by radiostereometric analysis (RSA) in addition to the conventional pelvis and hip X-ray exams. Early radiological loosening of one or both of the prosthesis components is identified at an early stage with RSA.

In case of for example infection or dislocation.

Questionnaires regarding Patient's satisfaction, Quality of life (EQ-5D), Activity level (UCLA), Harris Hip Score.

tantalum/inflammation

Stability of Uncemented Medially Stabilized TKA

A Comparative Study of Stem and Cup Fixation and Polyethylene Wear

Study of Systemic Impact of Trace Elements Release by Implantable Medical Devices. Identification of Biomarkers of Systemic Inflammation

Evaluation of Cemented and Cementless Fixation of Dual-mobility Hip Prosthesis in Elderly Patients With Osteoarthritis

Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

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