CClinicalTrials.gg
Status unknownNCT02294890Updated Nov 19, 2014

Knee Stiffness in Fibrosis Diathesis

An observational study in Knee Replacement Arthroplasty, Fibrosis and Dupuytren's Disease, sponsored by University Hospital Pellenberg. Status unknown. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-11-19.

Sponsored by University Hospital Pellenberg · Observational

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
50 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Knee Replacement Arthroplasty
  • Fibrosis
  • Dupuytren's Disease
03

In context

Dupuytren Contracture

76 studies on the registry are indexed under Dupuytren Contracture; 16 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 19 observational studies indexed under Dupuytren Contracture.

Browse Dupuytren Contracture studies →

Lead sponsor

University Hospital Pellenberg is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability 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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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,...
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureTotal knee arthroplasty
06

What researchers measure

Primary outcomes

  1. Range of movement of the operated knee at 12 months postoperatively

    Time frame: 12 months

  2. Additional procedures/interventions to gain motion

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

  2. KSS score for knee function

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 15336743 ↗
  • 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. PubMed 17145383 ↗
  • 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. PubMed 25002219 ↗
  • 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. PubMed 25201448 ↗
  • 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. PubMed 11307078 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02294890
Lead sponsor
University Hospital Pellenberg
Responsible party
Maarten Van Nuffel (Fellow, University Hospital Pellenberg) — Principal investigator
First posted
Nov 19, 2014
Start date
Jan 2015
Primary completion
Mar 2015 (estimated)
Completion
Apr 2015 (estimated)
Last update
Nov 19, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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