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Completed

NCT Number: NCT01501955

The Metaphyseal Hip Prosthesis - Total Hip

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

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Key information

Conditions

Osteoarthritis of the Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bravis Ziekenhuis Roosendaal

Roosendaal, 4708, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metaphyseal Hip Prosthesis

Device

Metaphyseal Hip Prosthesis (MHP) hip replacement

Other names: The Metaphyseal Hip Prosthesis

Stanmore

Device

Stanmore hip prosthesis

Other names: Stanmore hip prosthesis

Primary outcomes

  1. RSA Translation X

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

    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.

  2. RSA Translation Y

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

  3. RSA Translation Z

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

  4. RSA Rotation X

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

  5. RSA Rotation Y

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

  6. RSA Rotation Z

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

  7. RSA MTMP

    Time frame: 3 months, 6 months, 1 year and 2 years postoperatively

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

Secondary outcomes

  1. Number of Reported Device Related Complications

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

    Safety:

    • Frequency of serious device related complications.

  2. Harris Hip Score

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

    Harris Hip Score (HHS), a score to measure health and satisfaction after a hip prosthesis.

    The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points)

  3. DEXA

    Time frame: 1 and 2 years postoperative

    Efficacy: Bone density measured using the average DEXA score in each zone. For the long Stanmore the 7 Gruen zones were defined. For the short MHP stem an adjusted model with only 5 zones was used. The scan at 6 weeks is used as the baseline measurement to analyze if the bone density changes in the following years. At 1 year and 2 year follow up, percentual change is presented for both groups with respect to the 6 weeks DEXA score

  4. HOOS-Pain Subscale

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

    HOOS (Hip disability and Osteoarthritis Outcome Score) consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  5. HOOS-Symptom Subscale

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

    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  6. HOOS-ADL Subscale

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

    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  7. HOOS-Sport Subscale

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

    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  8. HOOS-QoL Subscale

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

    HOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and hip related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

  9. SF-12 Physical Summary Score

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

    12-Item Short-Form Health Survey (SF-12) presented in Physical (PS) and Mental summary (MS) scores (range 0-100).

    A zero score indicates the lowest level of health and 100 indicates the highest level of health.

  10. SF-12 Mental Summary Score

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

    SF-12 Score presented in Physical and Mental summary scores (range 0-100). A zero score indicates the lowest level of health and 100 indicates the highest level of health.

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Evaluation of the Safety and Efficiency of the Metaphyseal Hip Prosthesis - Total Hip Arthroplasty

Important dates

Study start
2012
Primary completion
2016
Study completion
2023
First posted
Dec 30, 2011
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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