- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02294890
Knee Stiffness in Fibrosis Diathesis
Does Fibrosis Diathesis Influence the Recovery of Knee Mobility After Total Knee Replacement?
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients undergoing a total knee replacement for primary gonarthrosis with a minimum follow-up of 1 year
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,…
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Range of movement of the operated knee at 12 months postoperatively
Time Frame: 12 months
|
12 months
|
|
Additional procedures/interventions to gain motion
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
- Increase of contracture or appearance of the nodules and contractures in the hand after the knee surgery.
Time Frame: 12 months
|
12 months
|
|
KSS score for knee function
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHPellenberg
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