Metacarpophalangeal Joint Reconstruction Using a Vascularized Cartilage and Bone Graft (MJRUVCBG)

November 8, 2011 updated by: Xu Zhang, The Second Hospital of Qinhuangdao

Phase 1 Study for Reconstruction of Metacarpophalangeal Joint Using a Vascularized Cartilage and Bone Graft From the Third Metacarpal

Traumatic cartilage loss of the joint is central to the development of joint failure in arthritis. The study on the use of a bone graft for reconstruction of metacarpophalangeal joint defects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The metacarpophalangeal joint is vital for hand function. Cartilage loss of the joint is central to the development of joint failure in arthritis. Although various treatments have been proposed, the management remains a challenging problem.Previous anatomical studies have shown that, at the base of the metacarpal, there were nutrient arteries inserting into the dorsum of the metacarpal. The nutrient arteries arise from the distal and middle dorsal carpal arches that run distally to the first to fourth dorsal metacarpal arteries (DMAs. These studies prompt us to use a reverse vascularized cartilage and bone graft based on the DMA. The metacarpal consists of a widened proximal base. The joint surface to the capitate is convex anteriorly and dorsally concave, where it extends to the styloid process on the dorsolateral aspect of the metacarpal base. The unique contour stimulates our imagination and creativity to use a portion of the joint surface for reconstruction of metacarpophalangeal joint defects. The purpose of this study is to report the novel technique and to evaluate the effectiveness of the treatment.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Qinhuangdao, Hebei, China, 066600
        • The second Hospital of Qinhuangdao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. a cartilage defect at either proximal or distal MCP joint;
  2. either an acute or old injury;
  3. loss of 1/4 of joint entire surface that seen on plain radiographs, CT scan, and intraoperative finding;
  4. and with or without MCP joint subluxation.

Exclusion Criteria:

  1. large defects involved double joint surfaces;
  2. the size of the defect involving less than 1/4 of the joint surface;
  3. associate with infection or other diseases that restrict to use the technique.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MCP joint
reconstruction of metacarpophalangeal (MCP) joint
Procedure: MCP joint
reconstruction of metacarpophalangeal (MCP) joint using a bone graft
Other Names:
  • MCP joint reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion; Arm, Shoulder and Hand questionnaire
Time Frame: 4 years
The active motions of the hand were measured by a goniometer. The patients rated their MCP joint pain, the donor joint pain, and scar pain using a line by a visual analogue scale (VAS). We used the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire to assess the hand function.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 4 years
joint pain is assessed using visual analogue scale
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Qinhuangdao

Investigators

  • Study Chair: Xu Zhang, MD, The second Hospital of Qinhuangdao

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 2, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XZhang201111
  • SHQ (Other Identifier: the second hospital of qinhuangdao)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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