The Metaphyseal Hip Prosthesis - Total Hip

NCT01501955 | Completed Results DMC

• 1 other identifier: BMETEU.CR.EU88 MHP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Hip

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (7)

• RSA Translation X

  Stem movement measured with RSA (radiostereometric analysis) along the x-axis in mm. RSA is a technique to accurately measure 3D movement of the prosthesis in the bone. The movement is measured with respect to the situation directly postoperative.

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA Translation Y

  Stem movement along the y-axis in mm. (measured with RSA)

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA Translation Z

  Stem movement along z-axis in mm (measured with RSA)

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA Rotation X

  Stem Rotation around X-axis in degrees (measured with RSA)

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA Rotation Y

  Stem rotation around the y-axis in degrees ( measured with RSA)

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA Rotation Z

  Stem rotation around the z-axis in degrees (measured with RSA)

  3 months, 6 months, 1 year and 2 years postoperatively

• RSA MTMP

  Maximum Total Point Motion (MTPM) measured with RSA. This is a mean for the total migration of the stem.

  3 months, 6 months, 1 year and 2 years postoperatively

Secondary Outcomes (10)

• Number of Reported Device Related Complications

  6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, 10 years postoperatively

• Harris Hip Score

  pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

• DEXA

  1 and 2 years postoperative

• HOOS-Pain Subscale

  pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

• HOOS-Symptom Subscale

  pre-operatively, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 6, 7, and 10 years postoperatively

Study Arms (2)

Stanmore

ACTIVE COMPARATOR

25 patients will have the Stanmore prosthesis

Device: Stanmore

Metaphyseal Hip Prosthesis

EXPERIMENTAL

25 patients will have the Metaphyseal Hip Prosthesis (MHP) prosthesis

Device: Metaphyseal Hip Prosthesis

Interventions

Metaphyseal Hip Prosthesis DEVICE

Metaphyseal Hip Prosthesis (MHP) hip replacement

Also known as: The Metaphyseal Hip Prosthesis

Metaphyseal Hip Prosthesis

Stanmore DEVICE

Stanmore hip prosthesis

Also known as: Stanmore hip prosthesis

Stanmore

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Bravis Ziekenhuis Roosendaal

Roosendaal, 4708, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The enrollment was terminated early leading to a small number of patients available for analysis.

Results Point of Contact

• Title: Linda Meijer
• Organization: Zimmer Biomet

linda.meijer@zimmerbiomet.com

+31786292929

Study Officials

• Stan Bell, MD

  Bravis Ziekenhuis Roosendaal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: December 30, 2011
• Study Start: October 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: December 1, 2023
• Last Updated: December 18, 2024
• Results First Posted: August 13, 2018

Record last verified: 2024-12

Locations

NL (1)