Metal-metal Articulations Versus Standard 28 mm Cementless Total Hip Arthroplasty

Metal-metal Articulations vs Standard 28 mm Cementless Total Hip Arthroplasty in Younger Patients. Randomized Studies

Younger hip patients often need revision of their hip replacement due to wear and loosening. Newer concepts (resurfacing and large head total hip replacement) with articulation surfaces in metal may reduce the wear, increase the longevity of the implant and give an improved function. The possible downside is that these concepts releases metal debris to the body. The investigators wish to see if the newer interventions are a clinical improvement compared to standard. The investigators also wish to investigate the extent of metal released to the body and any effect on the immune system. Finally the investigators wish to investigate the stability of these new implants and their ability to preserve the bone around the implant.

The investigators hypothesis is:

That the metal on metal articulations will not have better clinical outcomes than standard The resurfacing implant is expected to preserve the bone of the upper femoral bone. The implants are expected to be stabile within the first year.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Hip
• Intervention / Treatment: Device: articular surface replacement ASR, DePuy; Device: ReCap/Magnum modular head, Biomet; Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet; Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Naestved, Denmark, 4700
    • Naestved Hospital Dept. of orthop. surg.
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary hip osteoarthritis
• Secondary osteoarthritis due to mild dysplasia
• Age from 40 to 65 years

Exclusion Criteria:

• Dysplasia with CE angle < 25 degrees on the AP projection
• Severe femoral head deformation
• Reduced femoral neck length
• Leg length discrepancy more than 1 cm
• Need for restoration of offset
• Deformation after fractures or earlier osteotomies
• A previous hip arthroplasty
• Inflammatory arthritis
• Endocrinological disease with bone metabolic manifestations
• Renal disease
• Malignant disease
• Neuro/muscular or vascular diseases of the affected leg
• Osteoporosis
• Use of opioid pain killers due to other diseases
• High dose corticosteroids
• Obese with BMI > 35
• Pregnant or planning to be
• Ppresented problems that would prevent completing our follow-up program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: resurfacing; a hip replacement that leaves most of the underlying bone intact and mimics the natural biomechanical features of the hip joint	Device: articular surface replacement ASR, DePuy; posterolateral incision
Experimental: large head THA; a standard stemmed THA but with a large metal head, and a metal-metal articulation	Device: ReCap/Magnum modular head, Biomet; posterolateral incision
Active Comparator: 28 mm ceramics-polyethylene; a standard 28 mm head uncemented THA	Device: Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet; posterolateral incision
Active Comparator: 28 mm metal-polyethylene THA; a standard stemmed uncemented THA	Device: 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer); posterolateral incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion	range of motion in the hip joint evaluated by goniometer	Up to two months before surgery
Range of motion	Range of motion of the hip joint	8 weeks +/- 1 week
Range of motion	range of motion in the hip joint	6 months +/- 2 weeks
Range of motion	range of motion in the hip joint	1 year +/- 1 month
range of motion	range of motion in the hip joint	2 year +/- 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metal ions	Crome and cobalt ions in serum and whole blood.	Up to two months before surgery
BMD	bone mass density around the implants	Within the first week following surgery
RSA	radiostereommetry. Measurement of micromotions (subsidence, rotation and translations)of the implant in relation to the bone	Within the first week following surgery
HHS	Harris hip score. An investigator asssesed hip questionnaire including pain, function, deformities and range of motion	Up to two months before surgery
UCLA activity	University of California Los Angeles activity score. A score over the intensity of activities the patient engages in.	Up to two months before surgery
WOMAC	patient reported outcome of pain, stifness and disability during activities of daily living.	Up to two months before surgery
EQ-5d	a short quality of life measure. patient reported	Up to two months before surgery
T cell count	quantitative analysis of the level of T-cells in the blood	Up to two months before surgery
X-ray	an assesment of the placement of the metal cup. Inclination and anteversion.	within 2 years of surgery
steps	using a pedometer 1 week prior to each check up the annual step rate is calculated	Up to two months before surgery
sick leave	an assesment of the rehabilitation period following the intervention	assesed 6 months following surgery.
Metal ions	Crom and cobalt	8 weeks +/- 1 week
Metal ions	Crome and cobalt	6 months +/- 2 weeks
Metal ions	crome and cobalt	1 year +/- 1 month
metal ions	crome and cobalt	2 year +/- 1 month
BMD	bone mass desity around the implant	8 weeks +/- 1 week
BMD	Bone mass density around the implant	1 year +/- 1 month
BMD	Bone mass density around the implant	2 year +/- 1 month
RSA	Radiostereometry of implant	8 weeks +/- 1 week
RSA	Radiostereometry of implant	6 months +/- 2 weeks
RSA	Radiostereometry of implant	1 year +/- 1 month
RSA	Radiostereometry of implant	2 year +/- 1 month
HHS	Harris hip score	8 weeks +/- 1 week
HHS	Harris hip score	6 months +/- 2 weeks
HHS	Harris hip score	1 year +/- 1 month
HHS	Harris hip score	2 years +/- 1 month
UCLA activity	activity score	8 weeks +/- 1 week
UCLA activity	activity score	6 months +/- 2 weeks
UCLA activity	activity score	1 year +/- 1 month
UCLA activity	activity score	2 years +/- 1 month
WOMAC	self reported function	3 weeks
WOMAC	self reported function	6 weeks
WOMAC	self reported function	8 weeks +/- 1 week
WOMAC	self reported function	6 months +/- 2 weeks
WOMAC	self reported function	1 year +/- 1 month
WOMAC	self reported function	2 years +/- 1 month
EQ-5d	quality of life	8 weeks +/- 1 week
EQ-5d	quality of life	6 months +/- 2 weeks
EQ-5d	quality of life	1 year +/- 1 month
EQ-5d	quality of life	2 years +/- 1 month
T cell count	T cell count	8 weeks +/- 1 week
T cell count	T cell count	6 months +/- 2 weeks
T cell count	T cell count	1 year +/- 1 month
T cell count	T cell count	2 years +/- 1 month
steps	steps measured by pedometer during the week prior to check up	8 weeks +/- 1 week
steps	steps measured by pedometer during the week prior to check up	6 months +/- 2 weeks
steps	steps measured by pedometer during the week prior to check up	1 year +/- 1 month
steps	steps measured by pedometer during the week prior to check up	2 years +/- 1 month
blood loss	blood loss measured in mL	during surgery
days in hospital	days in hospital following surgery	from admission to discharge from hospital
complications	surgery and implant related complications	within the first 2 years following surgery
surgery time	time from skin is incised to skin is closed	during surgery
incision length	the length of the surgical incision in cm	during surgery

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: DePuy Orthopaedics; Zimmer Biomet; Region Zealand; Ministry of the Interior and Health, Denmark
• Investigators: Principal Investigator: Soeren Overgaard, MD, professor, phd, University of Southern Denmark

Publications and helpful links

General Publications

• Penny JO, Varmarken JE, Ovesen O, Nielsen C, Overgaard S. Metal ion levels and lymphocyte counts: ASR hip resurfacing prosthesis vs. standard THA: 2-year results from a randomized study. Acta Orthop. 2013 Apr;84(2):130-7. doi: 10.3109/17453674.2013.784657.
• Penny JO, Ovesen O, Varmarken JE, Overgaard S. Similar range of motion and function after resurfacing large-head or standard total hip arthroplasty. Acta Orthop. 2013 Jun;84(3):246-53. doi: 10.3109/17453674.2013.788435. Epub 2013 Mar 26.
• Nissen T, Douw K, Overgaard S. Patient-reported outcome of hip resurfacing arthroplasty and standard total hip replacement after short-term follow-up. Dan Med Bull. 2011 Oct;58(10):A4310.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): November 1, 2009
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Rehabilitation; T-Lymphocytes; Arthroplasty, Replacement, Hip; Bone Density; Chromium Alloys
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Cytochrome P-450 Enzyme Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Cytochrome P-450 CYP1A2 Inhibitors; Histamine H2 Antagonists; Cimetidine
• Other Study ID Numbers: VF20050133