Clinical trial NCT01501955: The Metaphyseal Hip Prosthesis - Total Hip
Official title: Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Hip
Keywords: Osteoarthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2011-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.

Detailed description: The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement at short term (1 year) and long term (10 years).

Bone remodeling will be analyzed at 10 years using DEXA (Dual Energy X-Ray Absorptiometry (bone scan test)) measurements.

This is a single-center prospective study with 25 patients in the study and 25 in the control group in open Randomized Clinical Trial.

Eligibility criteria: Inclusion Criteria:

* Candidates for a total hip replacement because of arthritis of the hip
* Patients with a good general condition
* Patients willing and able to participate in the clinical trial with a 10 years follow up and who have signed an inform consent
* Males and females
* Age between 55 and 75
* Absence or little presence of osteoporotic bone (t\>-2)
* ASA score 1 and 2

Exclusion Criteria:

* Patient with co morbidities that limit the physical abilities which may negatively influence the scores. Such co morbidities can for example be cardiac insufficiency or chronic respiratory diseases.
* Severe systematic diseases such as rheumatic arthritis and SLE.
* General osteoporosis (t\<-2).
* Hormonal conditions such as Paget disease, which reduces the bone density.
* Diseases that can negatively influence the 10 years life expectancy.
* Chronic use of corticosteroids.
* Extreme overweight defined as BMI above 35.
* Active bacterial infection.
* Mental weakness which could negatively influence the postoperative recovery and influence the ability to complete pain scores and other questionnaires.
* ASA score \>2.

Primary outcomes:
measure: RSA Translation X
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA Translation Y
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA Translation Z
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA Rotation X
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA Rotation Y
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA Rotation Z
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
measure: RSA MTMP
timeFrame: 3 months, 6 months, 1 year and 2 years postoperatively
Secondary outcomes:
measure: Number of Reported Device Related Complications
timeFrame: 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively
measure: Harris Hip Score
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: DEXA
timeFrame: 1 and 2 years postoperative
measure: HOOS-Pain Subscale
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: HOOS-Symptom Subscale
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: HOOS-ADL Subscale
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: HOOS-Sport Subscale
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: HOOS-QoL Subscale
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1,2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: SF-12 Physical Summary Score
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
measure: SF-12 Mental Summary Score
timeFrame: pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively
Other outcomes:
Locations:
city: Roosendaal
country: Netherlands
facility: Bravis Ziekenhuis Roosendaal
Study officials:
affiliation: Bravis Ziekenhuis Roosendaal
name: Stan Bell, MD
role: PRINCIPAL_INVESTIGATOR
References: