NCT01467752

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

Same day

First QC Date

November 2, 2011

Last Update Submit

November 8, 2011

Conditions

Volar Plate Injury, Thumb, Metacarpophalangeal Joint

Keywords

reconstructionmetacarpophalangeal jointbone graftMCP joint

Outcome Measures

Primary Outcomes (1)

  • Range of motion; Arm, Shoulder and Hand questionnaire

    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 Outcomes (1)

  • Pain

    4 years

Study Arms (1)

MCP joint

EXPERIMENTAL

reconstruction of metacarpophalangeal (MCP) joint

Procedure: MCP joint

Interventions

MCP jointPROCEDURE

reconstruction of metacarpophalangeal (MCP) joint using a bone graft

Also known as: MCP joint reconstruction
MCP joint

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second hospital of Qinhuangdao

Qinhuangdao, Hebei, 066600, China

Location

Related Publications (1)

  • Sebastin SJ, Mendoza RT, Chong AKS, Peng YP, Ono S, Chung KC, Lim AYT. Application of the dorsal metacarpal artery perforator flap for resurfacing soft-tissue defects proximal to the fingertip. Plast Reconstr Surg. 2011 Sep;128(3):166e-178e. doi: 10.1097/PRS.0b013e318221ddfa.

    PMID: 21865990RESULT

Related Links

Study Officials

  • Xu Zhang, MD

    The Second Hospital of Qinhuangdao

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

November 2, 2011

First Posted

November 9, 2011

Study Start

January 1, 2005

Primary Completion

January 1, 2005

Study Completion

December 1, 2009

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

CN(1)