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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01113762
• Other study ID #: VF20050133
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 28, 2010
• Last updated: December 17, 2017
• Start date: February 2007
• Est. completion date: November 2019

Study information

• Verified date: December 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: November 2019
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• articular surface replacement ASR, DePuy
posterolateral incision
• ReCap/Magnum modular head, Biomet
posterolateral incision
• Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet
posterolateral incision
• 28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)
posterolateral incision

Locations

Country	Name	City	State
Denmark	Naestved Hospital Dept. of orthop. surg.	Naestved
Denmark	Odense University hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	DePuy Orthopaedics, Ministry of the Interior and Health, Denmark, Region Zealand, Zimmer Biomet

Country where clinical trial is conducted

Denmark, 

Outcome

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

External Links

•   the danish homepage for the orthopaedic research unit, university of southern denmark