Comparison of Quadriceps-sparing Minimally Invasive and Medial Parapatellar Total Knee Arthroplasty

NCT01160835 | Completed Phase 4

• 1 other identifier: 9561705022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Quadriceps-sparing minimally invasive total knee arthroplasty (TKA) with side-cutting instruments has been proposed to limit surgical dissection without compromising the surgical outcome. We conducted a prospective, randomized study to compare the outcomes of quadriceps-sparing TKA with conventional medial parapatellar TKA, with two-year follow-up. We hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional medial parapatellar arthrotomy in TKA, in terms of postoperative recovery of quadriceps muscle strength, alignment of the prosthetic knee, and clinical outcome.

Conditions

Osteoarthritis

Keywords

total knee arthroplasty; minimally invasive; quadriceps-sparing; Quadriceps-sparing total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• To compare the clinic and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach

  Perioperative parameters: operative time, blood loss, Doses of narcotics for pain control, peri-operative complications Postoperative parameters: VAS, range of motion, knee functional score, isokinetic studies, radiographic alignment, complications

  2 years

Secondary Outcomes (1)

• To compare the survival and functional outcomes of total knee arthroplasty (TKA) respectively through a quadriceps-sparing (QS) approach and a MIS medial parapatellar (MP) approach at 2-year follow-up.

  5 and 10 years

Study Arms (2)

Quadriceps-sparing total knee arthroplasty

EXPERIMENTAL

Quadriceps-sparing arthrotomy with side-cutting instruments

Procedure: total knee arthroplastyinstruments

Medial parapatellar total knee arthroplasty

ACTIVE COMPARATOR

Medial parapatellar arthrotomy with front-cutting instruments

Procedure: total knee arthroplastyinstruments

Interventions

total knee arthroplastyinstruments PROCEDURE

Quadriceps-sparing arthrotomy with side-cutting instruments

Medial parapatellar total knee arthroplasty; Quadriceps-sparing total knee arthroplasty

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• advanced osteoarthritis with radiograph-evident narrowing of joint gap,
• with persistent symptoms after conservative treatment for at least 6 months, and
• patients' intention to receive the prosthetic TKA.

You may not qualify if:

• the knees with excessive deformity of femorotibial angle exceeding 15° varus or 10° valgus,
• flexion contracture exceeding 15°,
• active infection involving the knees, or
• knees received previous surgery.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Orthopedic Surgery, National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hongsen Chiang, M.D., Ph.D

  Department of orthopedic surgery of National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 12, 2010
• Study Start: May 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: November 1, 2007
• Last Updated: July 12, 2010

Record last verified: 2010-06

Locations

TW (1)