Correction of Angular Deformities in Knee Arthrosis

NCT02581605 | Active Not Recruiting

• 1 other identifier: 13/LO/1639
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

For participants whose leg bones don't line up properly, extra stress is placed on either the inner or outer side of the knee joint due to uneven transfer of body-weight. Gradually, this extra pressure wears away the smooth cartilage, resulting in osteoarthritis on that side of the knee joint. This problem is particularly common in young athletes and places them at risk of early osteoarthritis. An operation exists whereby one of the bones either side of the knee is cut ( an osteotomy) and hinged open to straighten the leg. This alteration redistributes body-weight more equally across the knee joint and is known to be effective in delaying and possibly preventing, the progression of knee osteoarthritis- especially in younger and physically more active patients in whom a knee replacement is undesirable. Currently it is possible to ( accurately) calculate the precise position of the bone cut and number of degrees correction required to straighten a leg using digital x-rays and three-dimensional CT scans. However there is no method of implementing this pre-operative plan during surgery so that the majority of surgeons rely on relatively crude and ipso facto unreliable intra-operative measurements as a guide. To improve the accuracy of this operation, the investigator propose the use of a custom-made 'cutting block', tailored for each individual patient and its shape will match the contour of the patient's bone to ensure it can only be placed in one position. Pre-cut slots and holes will then guide the saw cut and the number of degrees the bone in hinged open, as per the pre-operative plan; it functions as an intra-operative template for the surgeon. This study will primarily examine whether there is a close match between the planned and actual correction of leg deformities when using a patient-matched cutting-block.

Conditions

Arthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Final radiographic alignment is with two degrees of pre-operative plan in both coronal and sagittal

  24 months

Study Arms (2)

Osteotomy Arm

Patients due to undergo an osteotomy around the knee. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.

Device: Custom-made 'cutting block'

Partial Knee Replacement Arm

Patients due to undergo a partial knee replacement. To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.

Device: Custom-made 'cutting block'

Interventions

Custom-made 'cutting block' DEVICE

To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.

Osteotomy Arm; Partial Knee Replacement Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Osteotomy Arm: Target population: 42 Partial Knee Replacement Arm: Target population: 42

You may qualify if:

• All patients considered suitable candidates for an osteotomy around the knee.
• All patients consenting to an osteotomy around the knee.
• All patients considered medically fit for surgery.
• All patients must be between 18 to 70 years of age.

You may not qualify if:

• Patients not suitable for an osteotomy around the knee.
• Patients with collateral ligament(s) insufficiency.
• Patients who decline surgery.
• Patients lacking capacity to consent.
• Patients who do not understand English (written and verbal).
• Partial Knee Replacement Arm:
• All patients considered suitable candidates for a partial knee replacement
• All patients consenting to a partial knee replacement
• Patients not suitable for a partial knee replacement.
• Patients who decline surgery.
• Patients lacking capacity to consent.
• Patients under the age of eighteen.
• Patients who do not understand English (written and verbal).

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Charing Cross Hospital

London, W6 RF, United Kingdom

Location

Study Officials

• Professor Justin Cobb

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: October 21, 2015
• Study Start: November 1, 2014
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

GB (1)