NCT02294890

Brief Summary

At the standard follow-up moment one year after primary TKA for gonarthrosis, all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis. For both groups, the range of motion (ROM) of the operated knee at 3 and 6 months will be retrieved in the charts, the ROM at 12 months will be measured at that time. Also, additional procedures performed to increase ROM postoperatively will be retrieved from the charts (e.g. continuous passive motion, mobilization under anesthesia). Other causes for knee stiffness will have to be recorded, since these will be the most important exclusion criteria. In the patients with clear signs of finger contractures, any impression of increase of contracture over the past 12 months will be recorded.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 5, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

November 5, 2014

Last Update Submit

November 15, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • Range of movement of the operated knee at 12 months postoperatively

    12 months

  • Additional procedures/interventions to gain motion

    12 months

Secondary Outcomes (2)

  • - Increase of contracture or appearance of the nodules and contractures in the hand after the knee surgery.

    12 months

  • KSS score for knee function

    12 months

Study Arms (2)

Fibrosis diathesis

all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis.

Procedure: Total knee arthroplasty

No fibrosis diathesis

all patients will be checked for signs of fibrosis diathesis. This will be done by examining their hands for Dupuytren's nodules and contractures and recording risk factors associated with increased severity and risk of recurrence of Dupuytren's contracture. These include family history, bilateral DD, and ectopic lesions, age of onset less than 50 years, male gender, Ledderhose disease, first ray involvement, multiple ray involvement and ectopic fibromatosis. This way, two groups of patients will be identified: those with and those without signs of fibrosis diathesis.

Procedure: Total knee arthroplasty

Interventions

Fibrosis diathesisNo fibrosis diathesis

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who undergo a total knee arthroplasty for primary gonarthrosis at a minimal age of 50 years showing signs of fibrosis diathesis at presentation can be included. Patients who do not show signs of fibrosis diathesis will serve as a control group.

You may qualify if:

  • All patients undergoing a total knee replacement for primary gonarthrosis with a minimum follow-up of 1 year

You may not qualify if:

  • Patients undergoing a TKA for other reasons than primary gonarthrosis, e.g. after infection, posttraumatic arthritis,hemophilia,…
  • Patients who had other problems after their TKA resulting in knee stiffness, e.g. infection, bleeding,…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Abe Y, Rokkaku T, Ofuchi S, Tokunaga S, Takahashi K, Moriya H. An objective method to evaluate the risk of recurrence and extension of Dupuytren's disease. J Hand Surg Br. 2004 Oct;29(5):427-30. doi: 10.1016/j.jhsb.2004.06.004.

    PMID: 15336743BACKGROUND
  • Hindocha S, Stanley JK, Watson S, Bayat A. Dupuytren's diathesis revisited: Evaluation of prognostic indicators for risk of disease recurrence. J Hand Surg Am. 2006 Dec;31(10):1626-34. doi: 10.1016/j.jhsa.2006.09.006.

    PMID: 17145383BACKGROUND
  • Issa K, Rifai A, Boylan MR, Pourtaheri S, McInerney VK, Mont MA. Do various factors affect the frequency of manipulation under anesthesia after primary total knee arthroplasty? Clin Orthop Relat Res. 2015 Jan;473(1):143-7. doi: 10.1007/s11999-014-3772-x.

    PMID: 25002219BACKGROUND
  • Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.

    PMID: 25201448BACKGROUND
  • Smith SP, Devaraj VS, Bunker TD. The association between frozen shoulder and Dupuytren's disease. J Shoulder Elbow Surg. 2001 Mar-Apr;10(2):149-51. doi: 10.1067/mse.2001.112883.

    PMID: 11307078BACKGROUND

MeSH Terms

Conditions

FibrosisDupuytren Contracture

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsFibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 19, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

November 19, 2014

Record last verified: 2014-11