Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)

Osteoarthritis, Knee Clinical Trial

Official title:

Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799370
• Other study ID #: 2007.477
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category.

The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• age: 40 to 65 years old

• patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication

• one sided indication

• well understanding of information note by patient, non-opposition to perform the research

• Affiliation to a national health insurance program

Exclusion Criteria:

• age < 40 or > 65 years old

• medial osteoarthritis of knee of level superior to 2

• bilatéral indication

• patient opposition

• non affiliation to a national health insurance program

• law protected patients

• pregnancy and breast feeding

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Early weight bearing
Weight bearing performed immediately after surgery
• Delayed weight bearing
Weight bearing performed 2 months after surgery

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Lansdaal JR, Mouton T, Wascher DC, Demey G, Lustig S, Neyret P, Servien E. Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IKS score		one year follow-up
Secondary	IKS score		6 months follow-up
Secondary	VAS score of pain		at D1, D5, D15, M1, M2, M3, M6 and one year follow-up
Secondary	IKDC (International Knee Documentation Committee) score		at M2, M, M6 and one year follow-up
Secondary	Safety follow-up		during the one year follow-up