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Completed

NCT Number: NCT03836755

Evaluation of the Stability of Osseointegrated Implant in Amputees

The study concerns the technique of osseointegration that consists of inserting a titanium pin into the bone of the amputated limb. A removable external prosthesis will then be connected to the implant section that protrudes from the soft parts.

The benefits of using an osseointegrated prosthesis are the improved sensory feedback (osseoperception) and absence of the socket. This leads to better anchoring of the prosthesis to the abutment, greater control of the prosthesis and the absence of heat, pain, and pressure sores.

The osseointegrated prosthesis does not reduce the mobility of the limb and promotes good growth of bone and muscle mass. The aim of this study is to evaluate the stability of the osseointegrated implant in trans-femoral and trans-humeral amputees.

The main outcome: quantitative evaluation (rotations, translation and MTPM) of the stability of the implant bone interface by Roentgen Stereo-photogrammetric Analysis (RSA) and follow-up.

The secondary outcome: evaluation of the quality of life improvement in patients through clinical score and satisfaction survey.

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Key information

Conditions

Prosthesis Migration Amputation Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI<35 kg/m2
  • Problem in using socket

Exclusion criteria

  • Diabetes;
  • Peripheral vascular diseases;
  • Psychiatric problems;
  • Pregnancy;
  • Rheumatoid arthritis;
  • Neurovascular diseases;
  • Neurological deficits;
  • Amputation of the contralateral limb;
  • Infections in progress;
  • Immunosuppression;

Treatment and study plan

Metacos

Diagnostic Test

Evaluation of stability of implant by RSA technique

Primary outcomes

  1. Rotation

    Time frame: 24 months

    Rotations X, Y, Z (in degrees) of the implant with respect to the bone

  2. Translation

    Time frame: 24 months

    Translations X, Y, Z (in mm) of the implant with respect to the bone

Secondary outcomes

  1. Health-related quality of life

    Time frame: 24 months

    36-Item Short Form Survey (SF36 )

  2. Pain evaluation

    Time frame: 24 months

    Visual Analog Scale (VAS)

  3. Lower limb: Autonomy

    Time frame: 24 months

    Barthel Index

  4. lower limb: Mobility

    Time frame: 4 months

    Rivermead Mobility Index

  5. Upper limb: functionality

    Time frame: 24 months

    The Disabilities of the Arm, Shoulder and Hand (DASH)

  6. Upper Limb: Development and evaluation of the activities measure for upper limb amputees

    Time frame: 24 months

    Activities Measure for Upper Limb Amputees (AM-ULA)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
  • Scuola Universitaria Superiore Sant'Anna Pisa
  • University of Bologna

Registry information

Official study title

Evaluation of the Stability of Osseointegrated Implant in Upper Limb or Lower Limb Amputees

Acronym: METACOS

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Feb 11, 2019
Registry last updated
May 24, 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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