ORIF Distal Radius Blood Flow Restriction Therapy

Distal Radius Fractures Clinical Trial

— ORIF DR BFR  

Official title:

Effects of Blood Flow Restriction Rehabilitation After ORIF of Distal Radius Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136286
• Other study ID #: Pro000022755
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2019
• Est. completion date: January 1, 2027

Study information

• Verified date: November 2023
• Source: The Methodist Hospital Research Institute
• Contact: Haley Goble, MHA
• Phone: 7134413930
• Email: hmgoble[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients commonly experience a significant amount of muscular atrophy following open reduction internal fixation (ORIF) surgery of distal radius fractures, associated with an increased risk of re-injury, and an increase in time of recovery. A combination of low intensity resistance exercise and blood flow restriction (BFR) therapy has been shown to elicit responses similar to high intensity resistance exercise with reduced risk. We hypothesize that chronic low intensity resistance exercise combined with BFR will improve muscular strength, reduce skeletal muscle atrophy, and will enhance recovery.

Therefore, the specific aims of this study are as follows:

1. Determine if BFR added to standard post-operative rehab will prevent skeletal muscle atrophy and promote skeletal muscle growth during 12-weeks of rehab training compared to traditional rehab alone. The working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle growth and prevent atrophy to a greater extent than rehab alone.

2. Determine if BFR added to standard post-operative rehab will improve muscular strength following surgery compared to traditional rehab alone. Because strength can be attributed to skeletal muscle mass, the working hypothesis, founded on previous literature, is that combined rehab and BFR will enhance skeletal muscle strength and fatigue resistance to a greater extent than rehab alone.

3. Determine if BFR added to standard post-operative rehab will improve functional outcomes following surgery compared to traditional rehab alone. The working hypothesis, founded on previous literature is that BFR will improve functional outcomes over rehab alone.

Description:

he study will be a prospective randomized control trial consisting of subjects requiring ORIF of the distal radius. Subjects will be divided into two groups based on age, then subsequently be randomly divided into two groups following their inclusion in the study.

Groups will be normalized based on gender. One group will undergo the normal rehabilitation protocol for the hand and wrist as determined by Dr. Liberman. The study group will undergo rehabilitation protocol for distal radius fractures modified by use of a tourniquet for blood flow restriction during selected exercises. On the day of the procedure, the surgeon will measure the subject's forearm girth, the location of the largest circumference. The subject will then undergo the normal operative fixation of the distal radius fracture. A subject will be excluded from the study if they have had any prior surgeries on their affected wrist. At the subject's two week postoperative clinic visit, the physician will measure forearm girth. Study group subjects will begin physical therapy instructed BFR exercises at two weeks post operatively. Study group subjects will be taken through normal hand and wrist rehab protocol as well as BFR exercises. Control group subjects will do the same exercises and formal physical therapy rehab protocol as the study group without BFR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged 18+

• With acute fracture of distal radius requiring ORIF surgery

Exclusion Criteria:

• Exorbitant pain (VAS >8/10) related or unrelated to exercise

• Prior trauma or surgery to the observed limb

• Level 2 Obesity (BMI>35)

• Diabetes - Type II

• Cardiovascular, renal, liver or pulmonary disease

• Active infections

• Cancer (current or treated within the past 2 years)

• Bleeding or coagulation disorder

• Rapid weight change within the past year

• Physically unable to participate in the intervention

• Currently taking, or recently (w/in 1month of participation) taken prescribed or over the counter ergogenic aids or compounds known to be banned by the NCAA

• Unable to complete a minimum of 85% of the assigned rehabilitation sessions

Related Conditions & MeSH terms

• Distal Radius Fractures
• Radius Fractures
• Wrist Fractures

Intervention

Device:
• Blood Flow Restriction (BFR) Cuff
The intervention group will receive therapy with a blood flow restriction cuff that restricts blood flow at their individual limb occlusion pressure during specific exercises.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition / bone density	Soft tissue analysis of forearm and total body via DEXA scan.	DEXA scans will be recorded at the first rehabilitation visit (one week post-op), and then at two weeks, six weeks and 12 weeks following the initiation of rehabilitation.
Primary	Forearm girth	The location of the largest circumference will be measured by the operating surgeon. Values recorded in cm.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Primary	Grip strength	Grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Primary	Pinch grip strength	Pinch grip strength will be measured for both left and right hands using a handheld dynamometer. Values recorded in lbs.	Measurements will be recorded on the day of operative procedure, then at two, six and 12 weeks post-op.
Secondary	DASH survey	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
Secondary	Michigan Hand Outcomes survey	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.
Secondary	Patient Rated Wrist Evaluation	Patient reported outcome surveys will be completed by all participants to measure information relating to pain/symptoms and functional ability post-op.	This survey will be conducted before surgery, prior to physical therapy rehabilitation at two weeks post-op, then at two months, six months and one year post-operatively.