NCT01479738

Brief Summary

The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

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
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
Last Updated

November 28, 2011

Status Verified

November 1, 2011

Enrollment Period

6.6 years

First QC Date

November 19, 2011

Last Update Submit

November 24, 2011

Conditions

Recurrent Dislocation of Hand

Keywords

arthroplastygraftcapitateartery

Outcome Measures

Primary Outcomes (1)

  • range of motion

    Active range of motion of the hand were measured by a goniometer.

    37 to 46 months postoperatively

Secondary Outcomes (2)

  • grip strength

    37 to 46 months postoperatively

  • pinch strength

    37 to 46 months postoperatively

Study Arms (1)

Capitate bone grafting

EXPERIMENTAL

18 patients with PIP joint defects were included in the study. There were 13 male and 5 female patients with a mean age of 31 years (range, 18-47 years). The injury occurred in the right hand in 11 patients and on the left hand in 7. The injured PIP joints were in the index finger (n=7), long finger (n=9), and ring finger (n=2).

Procedure: Capitate bone grafting

Interventions

Capitate bone graftingPROCEDURE

Capitate bone graft transfer for PIP joint reconstruction

Capitate bone grafting

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • an articular defect at the proximal aspect of the PIP joint;
  • the defect larger than 5 mm × 5 mm in size based on intraoperative findings.

You may not qualify if:

  • large defects involved double joint surfaces;
  • the size of the defect less than 5 mm × 5 mm;
  • mult-digital articular defects that all required osteoarticular grafting;
  • 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)

  • Freiberg A. Management of proximal interphalangeal joint injuries. Can J Plast Surg. 2007 Winter;15(4):199-203. doi: 10.1177/229255030701500407.

    PMID: 19554177BACKGROUND

Related Links

Study Officials

  • Xu Zhang, M.D.

    The Second Hospital of Qinhuangdao

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2011

First Posted

November 24, 2011

Study Start

January 1, 2005

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

November 28, 2011

Record last verified: 2011-11

Locations

CN(1)